(265 days)
No
The summary describes dental implants and abutments, which are physical devices. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical testing and clinical outcomes, not algorithmic performance.
No
The device is described as dental implants and abutments intended to provide a support structure for prosthetic devices and restore chewing function, which is a structural and functional replacement, not primarily a therapeutic intervention.
No
Explanation: The document describes dental implants and abutments intended for oral implantation and rehabilitation, not for diagnosing medical conditions.
No
The device description clearly lists physical dental implants made of materials like titanium and titanium zirconium-alloy, with specific dimensions and types. This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the Straumann dental implants and abutments are for "oral implantation to provide a support structure for connected prosthetic devices." This describes a surgical implant used directly in the body for structural support.
- Device Description: The device description lists various types and sizes of dental implants, which are physical devices intended for surgical placement.
- Lack of IVD Characteristics: An IVD is a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided text does not mention any such use or interaction with biological specimens outside the body for diagnostic purposes.
- Performance Studies: The performance studies described focus on mechanical properties (dynamic fatigue, insertion torque) and clinical outcomes (implant failure rates, adverse events in smokers), which are relevant to the performance of a surgical implant, not an IVD.
Therefore, the Straumann dental implants and abutments described are surgical implants, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Straumann® BLX Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Straumann® TLX Dental Implants, SLActive®
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Other Straumann® Tissue Level and Bone Level Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.
Unless stated in specific indications, they can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Specific indications for use
Straumann® Roxolid® Bone Level Tapered Implant ø 2.9 mm
The Straumann® Roxolid® Bone Level Tapered implants ø 2.9 mm are indicated for single-unit reconstruction of incisors in the lower jaw and lateral incisors in the upper jaw.
Straumann® Roxolid® Standard Plus 4 mm Short Implants
Straumann® Roxolid® Standard Plus 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.
Straumann® Roxolid® Standard Plus 4 mm Short Implants are specifically indicated for:
Fixed denture prosthesis/splinted units (one implant per unit).
Pontic cases in combination with at least one longer implant.
Fully edentulous cases with at least one Straumann® Roxolid® Standard Plus 4 mm Short Implants in combination with 2 longer implants in the anterior region and at least four total implants.
Titanium Ø 3.3 mm implants
ø3.3 mm S and SP RN implants are to be used only for the following indications:
Partially dentate jaws with implant-borne, fixed constructions: combine with a Ø4.1 mm implants and splint the superstructure.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The SLActive® Implants from the Straumann® Dental Implants System includes:
SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10, and 12 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 NNC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.1 RN and Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø2.9 SC 10, 12 and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, 14. 16 and 18 mm
SLActive® and Roxolid®, BLX, Ø3.5 RB, 8, 10, 12, 14, 16, 18 mm
SLActive® and Roxolid®, BLX, Ø3.75 RB, Ø4.0 RB, Ø4.5 RB and Ø5.0 RB, 6, 8, 10, 12, 14, 16. 18 mm
SLActive® and Roxolid®, BLX, Ø5.5 WB and Ø6.5 WB, 6, 8, 10, 12, 14 and 16 mm
SLActive® and Roxolid®, Standard, TLX, Ø3.75 NT, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus Short, Ø4.1 RN and Ø4.8 RN and WN, 4 mm 4 mm Short Implants
All listed dental implants have already been cleared under the reference devices 510(k)s.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper or lower jaw
Indicated Patient Age Range
25-65 years old (from study data)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No significant changes have been performed to the subject implants since clearance so previously cleared bench data continue to be representative of the performance of the subject implants. For smokers' claim, a systematic literature search was performed to identify available data from studies where SLActive implants were placed in smokers. In 5 publications, 251 SLActive implants were placed in 237 patients with an age range of 25-65 years old. Published studies reported on titanium or titanium zirconium-alloy implants with SLActive surfaces and diameters ranging from 3.3 – 4.8 mm and lengths 8 – 12 mm. In the publications, adverse events such as failure to osseointegrate, peri-implantitis, spinning of implant during surgery, mobility of implant during surgery, late failure of implant, severe and mild bone loss, loosening of abutment, paresthesia, acrylic/porcelain chipping were reported. Adverse events were not reported at a higher rate in smokers compared to non-smokers. Additionally, implant failure rates were not found to be significantly different in smoking compared to non-smoking patients with SLActive implants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K083550, K111357, K121131, K122855, K140878, K153758, K162890, K173961, K181703, K191256, K200586, K202942, K210855, K212533, K123784
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Institut Straumann AG % Jennifer Jackson Sr. Director, Regulatory Affairs and Ouality Straumann USA. LLC 60 Minuteman Rd Andover, Massachusetts 01810
Re: K223083
Trade/Device Name: Straumann® SLActive® labeling changes Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE Dated: May 26, 2023 Received: May 26, 2023
Dear Jennifer Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223083
Device Name Straumann® SLActive® labeling changes
Indications for Use (Describe)
Straumann® BLX Dental Implants, SLActive®
Strauman® dental implants are indicated for functional and esthetic of the upper or lower jaw of edentulous or partially edentulous patients.
They can be used for immediate, early or late implantation or loss of natural teeth. The implants can be placed with immediate function for single-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Straumann® TLX Dental Implants, SLActive®
Strauman® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth restorations when qood primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Other Straumann® Tissue Level and Bone Level Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.
Unless stated in specific indications, they can be used for immediate, early or late implantation or loss of natural teeth. The implants can be placed with immediate function for multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Specific indications for use:
Straumann® Roxolid® Bone Level Tapered Implant Ø 2.9 mm
The Strauman® Roxolid® Bone Level Tapered implants ø 2.9 mm are indicated for single-unit reconstruction of incisors in the lower jaw and lateral incisors in the upper jaw.
Straumann® Roxolid® Standard Plus 4 mm Short Implants
Straumann® Roxolid® Standard Plus 4 mm Short Inplants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone with adequate bone primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing is between 10 to 12 weeks.
Straumann® Roxolid® Standard Plus 4 mm Short Implants are specifically indicated for:
- . Fixed denture prosthesis/splinted units (one implant per unit).
- Pontic cases in combination with at least one longer implant. .
- Fully edentulous cases with at least one Straumand Plus 4 mm Short Implants in combination with 2 longer . implants in the anterior region and at least four total implants.
Titanium Ø 3.3 mm implants
Ø3.3 mm S and SP RN implants are to be used only for the following indications:
Partially dentate jaws with implant-borne, fixed constructions: combine with a 04.1 mm implants and splint the superstructure.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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4
Straumann® SLActive® Labeling Changes
510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| | On the behalf of: Institut Straumann AG |
| | Institut Straumann AG
Peter Merian-Weg 12
4052 Basel, Switzerland. |
| Contact Person: | Jennifer M. Jackson, MS, RAC
Sr. Director, Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By: | Camila da Silva Esteves
External Consultant |
| Date of Submission: | June 21, 2023 |
Name of the Device
| Trade Names: | Straumann® SLActive® labeling changes |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implant |
| Regulation Number: | §872.3640 |
| Device Classification: | II |
| Product Code(s): | DZE |
| Classification Panel: | Dental |
| Proprietary Name: | Straumann® SLActive® |
5
Straumann® SLActive® Labeling Changes
510(k) Summary
Predicate Device(s)
Primary Predicate:
-
. K171784 – Straumann Dental Implant System
Reference Devices: -
K083550 Straumann Dental Implant System .
-
K111357 Straumann Narrow Neck CrossFit (NNC) 03.3mm Dental Implant System ●
-
K121131 BL, 04.1mm RC, SLActive® 8mm, TiZr and 10mm, 12, 14mm .
-
K122855 TL 04.1mm RN, S, SLActive® TiZr 6, 8, 10, 12, 14, 16mm Dental Implants .
-
K140878 Straumann Bone Level Tapered Implant .
-
K153758 Straumann Bone Level Tapered Implant .
-
K162890 BLT 02.9mm SC, SLA or SLActive®, RXD, Loxim, SC Closure Cap and . Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutments
-
K173961 Straumann BLX Implant System .
-
K181703 Straumann BLX Line Extension Implants, SRAs and Anatomic Abutments .
-
K191256 Straumann BLX Ø3.5 mm Implants .
-
K200586 Straumann TLX Implant System .
-
K210855 Straumann TLX Implant System .
-
K202942 Straumann 4 mm Short Implants .
-
K212533 BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants .
-
K123784 Straumann Dental Implant System .
Device Description
The SLActive® Implants from the Straumann® Dental Implants System includes:
SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14, and 16 mm SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14, and 16 mm SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10, and 12 mm SLActive® and Roxolid®, Standard Plus, Ø3.3 NNC, 8, 10, 12, and 14 mm
6
Straumann® SLActive® Labeling Changes
510(k) Summary
SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.1 RN and Ø4.8 RN, 6, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10 and 12 mm SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Bone Level Tapered, Ø2.9 SC 10, 12 and 14 mm SLActive® and Roxolid®, Bone Level Tapered, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, 14. 16 and 18 mm SLActive® and Roxolid®, BLX, Ø3.5 RB, 8, 10, 12, 14, 16, 18 mm SLActive® and Roxolid®, BLX, Ø3.75 RB, Ø4.0 RB, Ø4.5 RB and Ø5.0 RB, 6, 8, 10, 12, 14, 16. 18 mm SLActive® and Roxolid®, BLX, Ø5.5 WB and Ø6.5 WB, 6, 8, 10, 12, 14 and 16 mm SLActive® and Roxolid®, Standard, TLX, Ø3.75 NT, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm SLActive® and Roxolid®, Standard, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm SLActive® and Roxolid®, Standard Plus, TLX, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm SLActive® and Roxolid®, Standard Plus, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm SLActive® and Roxolid®, Standard Plus Short, Ø4.1 RN and Ø4.8 RN and WN, 4 mm 4 mm Short Implants
All listed dental implants have already been cleared under the reference devices 510(k)s.
Intended Use
Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.
Indications for Use
Straumann® BLX Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.
7
Straumann® SLActive® Labeling Changes
510(k) Summary
They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multipletooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Straumann® TLX Dental Implants, SLActive®
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Other Straumann® Tissue Level and Bone Level Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.
Unless stated in specific indications, they can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Specific indications for use
Straumann® Roxolid® Bone Level Tapered Implant ø 2.9 mm
The Straumann® Roxolid® Bone Level Tapered implants ø 2.9 mm are indicated for single-unit reconstruction of incisors in the lower jaw and lateral incisors in the upper jaw.
Straumann® Roxolid® Standard Plus 4 mm Short Implants
Straumann® Roxolid® Standard Plus 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.
Straumann® Roxolid® Standard Plus 4 mm Short Implants are specifically indicated for:
Fixed denture prosthesis/splinted units (one implant per unit).
8
Straumann® SLActive® Labeling Changes
510(k) Summary
Pontic cases in combination with at least one longer implant.
Fully edentulous cases with at least one Straumann® Roxolid® Standard Plus 4 mm Short Implants in combination with 2 longer implants in the anterior region and at least four total implants.
Titanium Ø 3.3 mm implants
ø3.3 mm S and SP RN implants are to be used only for the following indications:
Partially dentate jaws with implant-borne, fixed constructions: combine with a Ø4.1 mm implants and splint the superstructure.
Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICES |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K223083 | K171784 | K083550, K111357, K121131, K122855, K140878, K153758, K162890, K173961, K181703, K191256, K200586, K202942, K210855, K212533, K123784 |
| Material | Titanium - Zirconium alloy | Titanium - Zirconium alloy
Titanium Grade 4 | Titanium-Zirconium alloy |
| Surface
Treatment | SLActive® - Hydrophilic, sandblasted, large grit, acid etched. | SLActive® - Hydrophilic, sandblasted, large grit, acid etched. | |
| Implant to
Abutment
Connection | TorcFit®
CrossFit®
SynOcta® | SynOcta®
CrossFit® | TorcFit®
CrossFit®
SynOcta® |
| Implant
Diameter | 2.9mm, 3.3mm, 3.5mm, 3.75mm, 4.0mm, 4.1mm, 4.5mm, 4.8mm, 5.0mm, 5.5mm, 6.5mm | 3.3mm, 4.1mm and 4.8mm | 2.9mm, 3.3mm, 3.5mm, 3.75mm, 4.0mm, 4.1mm, 4.5mm, 4.8mm, 5.0mm, 5.5mm, 6.5mm |
| Implant
Length | 4, 6, 8, 10, 12, 14, 16 and
18mm | 6, 8, 10, 12, 14, 16 and 18mm | 4, 6, 8, 10, 12, 14, 16 and
18mm |
| Implant
Design | Tissue level (parallel and fully
tapered wall)
Bone level (parallel, tapered and
fully tapered wall) | Tissue level (parallel wall)
Bone level (parallel and tapered
wall) | Tissue level (parallel and fully
tapered wall)
Bone level (parallel, tapered and
fully tapered wall) |
Table 1 – Comparison of subject device versus primary predicate device
9
Straumann® SLActive® Labeling Changes
510(k) Summary
Labeling Changes and Performance Testing
The labelling changes that are being presented in this 510(k) were evaluated according to the FDA guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device". The proposed 510(k) does not intend to introduce new implants neither to modify cleared implants design. The purpose of this premarket notification is to revise the labeling to describe that the results of recent clinical studies on outcomes of SLActive implants in smokers are encouraging (Alsahhaf, 2019, Xiao, 2021, Chen 2017, Sener 2010, Luongo 2016). The proposed claim is supported by a literature review. In addition, changes to the Indications for Use wording were done, as well as general changes to the Instructions for Useto reflect the state-of-the-art of Straumann implant systems data and to improve the readability and clarity of the content without affecting the safety or effectiveness of the devices. Table 2 shows the substantial equivalence discussion for the proposed Indications for Use against the previously approved verbiage.
The presented Indications for Use are equivalent to the primary predicate and reference devices. The differences in the wording do not change the application of the devices. All indications allow for implant placement in the jaw, providing support for single-tooth or multipletooth and allowing for immediate loading when good primary stability is achieved. The prosthetic restorations information in some Indications for Use was relocated to the device description for better understanding. The use of 4 or more implants for fully edentulous patients is common knowledge and was removed from some Indications for Use. The new specific Indications for Use for ø 3.3 mm implants provide more details on the recommended clinical procedure. Additionally, the section Precaution of the Instructions for Use brings attention to the use of narrow implants in the molar region.
10
Straumann® SLActive® Labeling Changes
510(k) Summary
Table 2 Indications for Use comparison table
- for the purpose of this table, the acronym IFU refers to Instructions for Use
| K
NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE
INDICATIONS FOR USE
(K171784) | REFERENCE PREDICATE DEVICE
INDICATIONS FOR USE | EQUIVALENCE DISCUSSION |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K083550 | IFU: 704333
Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
Unless stated in specific indications, theyimplantation following the extraction or
loss of natural teeth. The implants can be
placed with immediate function for single-
tooth and/or multiple-tooth restorations
when good primary stability is achieved
and with appropriate occlusal loading to
restore chewing function.
Titanium Ø 3.3 mm implants
Ø3.3 mm S and SP RN implants are to be
used only for the following indications:
Partially dentate jaws with implant-borne,
fixed constructions: combine with a Ø4.1
mm implants and splint the
superstructure. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients.
Straumann® Dental implants are
indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference predicate - K083550:
Straumann® ROXOLID dental implants are
suitable for the treatment of oral endosteal
implantation in the upper and lower jaw and for
the functional and aesthetic oral rehabilitation of
edentulous and partially dentate patients
(unless specific indications and limitations are
present, as stated below). Straumann®
ROXOLID dental implants can also be used for
immediate or early implantation following
extraction or loss of natural teeth. Implants can
be placed with immediate function on single-
tooth and/or multiple tooth applications when
good primary stability is achieved and with
appropriate occlusal loading, to restore
chewing functions. The prosthetic restorations
used are single crowns, bridges and partial or
full dentures, which are connected to the
implants by the corresponding elements
(abutments). When placing implants in the
posterior region we recommend using only
large diameter implants. In cases of fully
edentulous patients, 4 or more implants must
be used in immediately loaded cases.
Specific indications for small diameter (Ø3.3
mm) implants:
Because of their reduced mechanical stability,
small diameter implants are only used in cases
with a low mechanical load. Placement in the
molar region is not recommended. | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding.
The use of 4 or more implants for
fully edentulous patients is
common knowledge and were
removed from the indications for
use.
The new specific Indications for
Use for Ø 3.3 mm implants
provides more details on the
recommended clinical procedure.
Additionally, the section
Precaution of the IFU show
brings attention to the use in
molar region. |
11
Straumann® SLActive® Labeling Changes
| K
NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE
INDICATIONS FOR USE
(K171784) | REFERENCE PREDICATE DEVICE
INDICATIONS FOR USE | EQUIVALENCE DISCUSSION |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K111357 | IFU 704333
Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
Unless stated in specific indications, they
can be used for immediate, early or late
implantation following the extraction or
loss of natural teeth. The implants can be
placed with immediate function for single-
tooth and/or multiple-tooth restorations
when good primary stability is achieved
and with appropriate occlusal loading to
restore chewing function.
Titanium Ø 3.3 mm implants
Ø3.3 mm S and SP RN implants are to be
used only for the following indications:
Partially dentate jaws with implant-borne,
fixed constructions: combine with a Ø4.1
mm implants and splint the
superstructure. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K111357:
Straumann® dental implants are suitable for the
treatment of oral endosteal implantation in the
upper and lower jaw and for the functional and
aesthetic oral rehabilitation of edentulous and
partially dentate patients. Straumann® dental
implants can also be used for immediate or
early implantation following extraction or loss of
natural teeth. Implants can be placed with
immediate function on single-tooth and/or
multiple tooth applications when good primary
stability is achieved and with appropriate
occlusal loading, to restore chewing function.
The prosthetic restorations used are single
crowns, bridges and partial or full dentures,
which are connected to the implants by the
corresponding components (abutments). When
placing implants in the posterior region, we
recommend using only large diameter implants.
In cases of fully edentulous patients, 4 or more
implants must be used in immediately loaded
cases.
Small Diameter Implants (Ø 3.3 mm)
Because of their reduced mechanical stability,
small diameter implants are only used in cases
with low mechanical load. Placement in the
moral region is not recommended. | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding.
The use of 4 or more implants
for fully edentulous patients is
common knowledge and were
removed from the indications for
use. The new specific
Indications for Use for Ø 3.3 mm
implants provides more details
on the recommended clinical
procedure. Additionally, the
section Precaution of the IFU
show brings attention to the use
in molar region. |
12
Straumann® SLActive® Labeling Changes
| K
NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE
INDICATIONS FOR USE
(K171784) | REFERENCE PREDICATE DEVICE
INDICATIONS FOR USE | EQUIVALENCE DISCUSSION |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K121131 | IFU 704333
Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
Unless stated in specific indications, they
can be used for immediate, early or late
implantation following the extraction or
loss of natural teeth. The implants can be
placed with immediate function for single-
tooth and/or multiple-tooth restorations
when good primary stability is achieved
and with appropriate occlusal loading to
restore chewing function. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K121131:
The Straumann® dental implants are suitable
for the treatment of oral endosteal implantation
in the upper and lower jaw and for the functional
and esthetic oral rehabilitation of edentulous
and partially dentate patients (unless specific
indications and limitations are specified).
Straumann® dental implants can be used for
immediate or early implantation following
extraction or loss of natural teeth. Implants can
be placed with immediate function on single-
tooth and/or multiple tooth applications when
good primary stability is achieved and with
appropriate occlusal loading, to restore
chewing function. The prosthetic restorations
are single crown, bridges and partial or full
denture, which are connected to the implants by
the corresponding elements (abutments).
When placing implants in the posterior region,
we recommend using only large diameter
implants. In cases of fully edentulous patients,
4 or more implants must be used in immediately
loaded cases. | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding.
The use of 4 or more implants for
fully edentulous patients is
common knowledge and were
removed from the indications for
use. |
13
Straumann® SLActive® Labeling Changes
| K
NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE
INDICATIONS FOR USE
(K171784) | REFERENCE PREDICATE DEVICE
INDICATIONS FOR USE | EQUIVALENCE DISCUSSION |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K122855 | IFU 704333
Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
Unless stated in specific indications, they
can be used for immediate, early or late
implantation following the extraction or
loss of natural teeth. The implants can be
placed with immediate function for single-
tooth and/or multiple-tooth restorations
when good primary stability is achieved
and with appropriate occlusal loading to
restore chewing function. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K122855:
Straumann® dental implants are suitable for the
treatment of oral endosteal implantation in the
upper and lower jaw and for the functional and
esthetic oral rehabilitation of edentulous and
partially dentate patients (unless specific
implants and limitations are present, as stated
below). Straumann® dental implants can also
be used for immediate or early implantation
following extraction or loss of natural teeth.
Implants can be placed with immediate function
on single-tooth and/or multiple tooth
applications when good primary stability is
achieved and with appropriate occlusal loading,
to restore chewing function. The prosthetic
restorations used are single crowns, bridges
and partial or full dentures, which are
connected to the implants by corresponding
elements (abutments). When placing implants
in the posterior region, we recommend using
only larger diameter implants. In cases of fully
edentulous patients, 4 or more implants must
be used in immediate loaded cases. | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding.
The use of 4 or more implants for
fully edentulous patients is
common knowledge and were
removed from the indications for
use. |
14
Straumann® SLActive® Labeling Changes
| K
NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE
INDICATIONS FOR USE
(K171784) | REFERENCE PREDICATE DEVICE
INDICATIONS FOR USE | EQUIVALENCE DISCUSSION |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K140878 | IFU 704333
Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
Unless stated in specific indications, they
can be used for immediate, early or late
implantation following the extraction or
loss of natural teeth. The implants can be
placed with immediate function for single-
tooth and/or multiple-tooth restorations
when good primary stability is achieved
and with appropriate occlusal loading to
restore chewing function. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K140878:
Straumann® dental implants are indicated for
oral endosteal implantation in the upper and
lower jaw arches for the functional and
aesthetic oral rehabilitation of edentulous and
partially dentate patients. Straumann® dental
implants are also indicated for immediate or
early implantation following extraction or loss of
natural teeth. Implants can be placed with
immediate function on single-tooth and/or
multiple tooth applications when good primary
stability is achieved and with appropriate
occlusal loading, to restore chewing function.
The prosthetic restorations used are single
crowns, bridges and partial or full dentures,
which are connected to the implants through
the corresponding components (abutments). In
cases of fully edentulous patients, 4 or more
implants must be used in immediately loaded
cases. | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding.
The use of 4 or more implants for
fully edentulous patients is
common knowledge and were
removed from the indications for
use. |
15
Straumann® SLActive® Labeling Changes
| K
NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE
INDICATIONS FOR USE
(K171784) | REFERENCE PREDICATE DEVICE
INDICATIONS FOR USE | EQUIVALENCE DISCUSSION |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K153758 | Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
Unless stated in specific indications, they
can be used for immediate, early or late
implantation following the extraction or
loss of natural teeth. The implants can be
placed with immediate function for single-
tooth and/or multiple-tooth restorations
when good primary stability is achieved
and with appropriate occlusal loading to
restore chewing function. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jawarches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K153758
Straumann® dental implants are indicated for
oral endosteal implantation in the upper and
lower jaw arches for the functional and
aesthetic oral rehabilitation of edentulous and
partially dentate patients. Straumann® dental
implants are also indicated for immediate or
early implantation following extraction or loss of
natural teeth. Implants can be placed with
immediate function on single-tooth and/or
multiple tooth applications when good primary
stability is achieved and with appropriate
occlusal loading to restore chewing function.
The prosthetic restorations used are single
crowns, bridges and partial or full dentures,
which are connected to the implants through
the corresponding components (abutments). | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding.
The new specific Indications for
Use for Ø3.3 mm implants
provides more details on the
recommended clinical procedure.
Additionally, the section
Precaution of the IFU show
brings attention to the use in
molar region |
16
Straumann® SLActive® Labeling Changes
| K
NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE
INDICATIONS FOR USE
(K171784) | REFERENCE PREDICATE DEVICE
INDICATIONS FOR USE | EQUIVALENCE DISCUSSION |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K162890 | IFU 704333
Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
Unless stated in specific indications, they
can be used for immediate, early or late
implantation following the extraction or
loss of natural teeth. The implants can be
placed with immediate function for single-
tooth and/or multiple-tooth restorations
when good primary stability is achieved
and with appropriate occlusal loading to
restore chewing function.
Straumann® Roxolid® Bone Level
Tapered Implant Ø 2.9 mm
The Straumann® Roxolid® Bone Level
Tapered implants Ø 2.9 mm are indicated
for single-unit reconstruction of incisors
in the lower jaw and lateral incisors in the
upper jaw. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K162890
Straumann® Bone Level Tapered Implants
Ø 2.9 mm are indicated for oral endosteal
implantation in the upper and lower jaw and for
the functional and aesthetic oral rehabilitation of
patients with missing teeth. Straumann® Bone
Level Tapered Implants Ø 2.9 mm can also be
used for immediate or early implantation
following extraction or loss of natural teeth.
Implants can be placed with immediate function
on single-tooth and/or multiple tooth
applications when good primary stability is
achieved and with appropriate occlusal loading
to restore chewing function. The prosthetic
restorations are connected to the implants
through the corresponding components
(abutments).
The Straumann® Bone Level Tapered Implants
Ø 2.9 mm are indicated for reconstruction of
missing incisors in the lower jaw and lateral
incisors in the upper jaw. | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding.
The specific indications for Ø 2.9
mm implants are the same as the
reference device. |
| K
NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE
INDICATIONS FOR USE
(K171784) | REFERENCE PREDICATE DEVICE
INDICATIONS FOR USE | EQUIVALENCE DISCUSSION |
| K173961 | IFU 702110
Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
They can be used for immediate, early or
late implantation following the extraction
or loss of natural teeth. The implants can
be placed with immediate function for
single-tooth and/or multiple-tooth
restorations when good primary stability
is achieved and with appropriate occlusal
loading to restore chewing function. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K173961
Straumann® BLX Implants are suitable for
endosteal implantation in the upper and lower
jaw and for the functional and esthetic oral
rehabilitation of edentulous and partially
edentulous patients. BLX Implants can be
placed with immediate function on single-tooth
applications when good primary stability is
achieved and with appropriate occlusal loading
to restore chewing function. The prosthetic
restorations are connected to the implants
through the corresponding abutment
components. | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The single-tooth restoration
would be the worst case due to
the higher masticatory load.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding. |
| K181703 | IFU 702110
Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
They can be used for immediate, early or
late implantation following the extraction
or loss of natural teeth. The implants can
be placed with immediate function for
single-tooth and/or multiple-tooth
restorations when good primary stability
is achieved and with appropriate occlusal
loading to restore chewing function. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K181703
Straumann® BLX Implants are suitable for
endosteal implantation in the upper and lower
jaw and for the functional and esthetic oral
rehabilitation of edentulous and partially
edentulous patients. BLX Implants can be
placed with immediate function on single-tooth,
bar and bridge applications when good primary
stability is achieved and with appropriate
occlusal loading to restore chewing function.
The prosthetic restorations are connected to
the implants through the corresponding
abutment components. | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The single-tooth restoration
would be the worst case due to
the higher masticatory load.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding. |
| K
NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE
INDICATIONS FOR USE
(K171784) | REFERENCE PREDICATE DEVICE
INDICATIONS FOR USE | EQUIVALENCE DISCUSSION |
| K191256 | IFU 702110
Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
They can be used for immediate, early or
late implantation following the extraction
or loss of natural teeth. The implants can
be placed with immediate function for
single-tooth and/or multiple-tooth
restorations when good primary stability
is achieved and with appropriate occlusal
loading to restore chewing function. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K191256
Straumann® BLX Implants are suitable for
endosteal implantation in the upper and lower
jaw and for the functional and esthetic oral
rehabilitation of edentulous and partially
edentulous patients. BLX Implants can be
placed with immediate function on single-tooth,
bar and bridge applications when good primary
stability is achieved and with appropriate
occlusal loading to restore chewing function.
The prosthetic restorations are connected to
the implants by the corresponding abutment
components. | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The single-tooth restoration
would be the worst case due to
the higher masticatory load.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding. |
17
Straumann® SLActive® Labeling Changes
18
Straumann® SLActive® Labeling Changes
19
Straumann® SLActive® Labeling Changes
| K
NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE
INDICATIONS FOR USE
(K171784) | REFERENCE PREDICATE DEVICE
INDICATIONS FOR USE | EQUIVALENCE DISCUSSION |
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| K200586 | IFU 704450
Straumann® dental implants are
indicated for the functional and esthetic
oral rehabilitation of the upper or lower
jaw of edentulous or partially edentulous
patients. They can be used for
immediate, early or late implantation
following the extraction or loss of natural
teeth. The implants can be placed with
immediate function for single-tooth
and/or multiple-tooth restorations when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K200586
Straumann® TLX Implants are suitable for
endosteal implantation in the upper and lower
jaws and for the functional and esthetic oral
rehabilitation of edentulous and partially
edentulous patients. TLX Implants can be
placed with immediate function on single-tooth
and multi-unit restorations when good primary
stability is achieved and with appropriate
occlusal loading to restore chewing function.
The prosthetic restorations are connected to
the implants through the corresponding
abutment components. | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth on
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding. |
| K202942 | IFU 704333
Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
Unless stated in specific indications, they
can be used for immediate, early or late
implantation following the extraction or
loss of natural teeth. The implants can be
placed with immediate function for single-
tooth and/or multiple-tooth restorations
when good primary stability is achieved
and with appropriate occlusal loading to
restore chewing function.
Straumann® Roxolid® Standard Plus
4 mm Short Implants
Straumann® Roxolid® Standard Plus 4
mm Short Implants are indicated for fixed
or removable reconstruction in situations
of moderate to severely atrophic jawbone
with adequate bone quality that allows
primary stability after implant insertion,
where a longer implant cannot be placed
due to limited vertical bone height. The
recommended healing time before
loading is between 10 to 12 weeks.
Straumann® Roxolid® Standard Plus 4
mm Short Implants are specifically
indicated or:
• Fixed denture
prosthesis/splinted units (one
implant per unit).
• Pontic cases in combination with
at least one longer implant.
• Fully edentulous cases with at
least two Straumann® Roxolid®
Standard Plus 4 mm Short
Implants in combination with 2
longer implants in the anterior
region. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K202942
Straumann® 4 mm Short Implants are indicated
for fixed or removable reconstruction in
situations of moderate to severely atrophic
jawbone with adequate bone quality that allows
primary stability after implant insertion, where a
longer implant cannot be placed due to limited
vertical bone height. The recommended healing
time before loading is between 10 to 12 weeks.
The 4 mm Short Implants are specifically
recommended for:
• Fixed denture prosthesis/splinted units
(one implant per unit).
• Pontic cases in combination with at
least one longer implant.
• Fully edentulous cases with at least one
4 mm Short Implant in combination with
2 longer implants in the anterior region
and at least four total implants. | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding.
The specific indication for 4mm
Short implants is the same as the
reference predicate. |
| K210855 | IFU 702110 | Straumann® Dental implants are
indicated for oral endosteal | Reference Predicate - K210855 | Equivalent |
| K
NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE
INDICATIONS FOR USE
(K171784) | REFERENCE PREDICATE DEVICE
INDICATIONS FOR USE | EQUIVALENCE DISCUSSION |
| | Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
They can be used for immediate, early or
late implantation following the extraction
or loss of natural teeth. The implants can
be placed with immediate function for
single-tooth and/or multiple-tooth
restorations when good primary stability
is achieved and with appropriate occlusal
loading to restore chewing function | implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | The Straumann® BLX Implants are suitable for
oral and endosteal implantation in the upper
and lower jaw and for the functional and
esthetic oral rehabilitation of edentulous and
partially dentate patients. Straumann® BLX
implants can be used for immediate or early
implantation following extraction or loss of
natural teeth. Implants can be placed with
immediate function on single-tooth and/or
multiple-tooth applications when good primary
stability is achieved and with appropriate
occlusal loading, to restore chewing function.
The prosthetic restorations used are single
crowns, bridges and partial or full dentures,
which are connected to the implants by the
corresponding elements (abutments). | All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding. |
| K212533 | IFU 702110
Straumann® dental implants are
indicated for functional and esthetic oral
rehabilitation of the upper or lower jaw of
edentulous or partially edentulous
patients.
They can be used for immediate, early or
late implantation following the extraction
or loss of natural teeth. The implants can
be placed with immediate function for
single-tooth and/or multiple-tooth
restorations when good primary stability
is achieved and with appropriate occlusal
loading to restore chewing function | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower jaw
arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are indicated for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple-tooth applications when
good primary stability is achieved and
with appropriate occlusal loading to
restore chewing function. The
prosthetic restorations are single
crowns, bridges and partial or full
dentures, which are connected to the
implants through the corresponding
components (abutments). | Reference Predicate - K212533
The Straumann® BLX Implants are suitable for
oral and endosteal implantation in the upper
and lower jaw and for the functional and
esthetic oral rehabilitation of edentulous and
partially dentate patients. Straumann® BLX
implants can be used for immediate or early
implantation following extraction or loss of
natural teeth. Implants can be placed with
immediate function on single-tooth and/or
multiple-tooth applications when good primary
stability is achieved and with appropriate
occlusal loading, to restore chewing function.
The prosthetic restorations used are single
crowns, bridges and partial or full dentures,
which are connected to the implants by the
corresponding elements (abutments). | Equivalent
All indications allow for implant
placement in jaw, providing
support for single-tooth or
multiple-tooth and allowing for
immediate loading when good
primary stability is achieved.
The prosthetic restorations
information was not excluded
from the Instructions for Use but
relocated to the device
description for better
understanding. |
20
Straumann® SLActive® Labeling Changes
21
Straumann® SLActive® Labeling Changes
22
Straumann® SLActive® Labeling Changes
510(k) Summary
The design of the subject implants has already been reviewed under the referenced predicate and reference device 510(k)s. The subject implants are provided sterile via gamma irradiation and are sterilized after final packaging. The sterilization process for the subject implants as recommended in the labeling was validated to a sterility assurance level (SAL) of 10·6 in accordance with ISO 11137-1, "Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05". The validation method used was the over kill bioburden (or VDmax25) method in accordance with ISO 11137- 2, "Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose". The shelf life is 5 years. The subject implants will not be marketed as non-pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device. Biological assessment has been performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices.
The subject implants have obtained the status of MR Conditional per K180540. The MR Conditional tests were conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment".
Dynamic fatigue assessment was conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants". The test covers permanent restoration of the implants without failure.
Insertion tests were performed for the subject implants and showed that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure.
23
K223083 – Traditional 510(k) Straumann® SLActive® Labeling Changes
510(k) Summary
No significant changes have been performed to the subject implants since clearance so previously cleared bench data continue to be representative of the performance of the subject implants. For smokers' claim, a systematic literature search was performed to identify available data from studies where SLActive implants were placed in smokers. In 5 publications, 251 SLActive implants were placed in 237 patients with an age range of 25-65 years old. Published studies reported on titanium or titanium zirconium-alloy implants with SLActive surfaces and diameters ranging from 3.3 – 4.8 mm and lengths 8 – 12 mm. In the publications, adverse events such as failure to osseointegrate, peri-implantitis, spinning of implant during surgery, mobility of implant during surgery, late failure of implant, severe and mild bone loss, loosening of abutment, paresthesia, acrylic/porcelain chipping were reported. Adverse events were not reported at a higher rate in smokers compared to non-smokers. Additionally, implant failure rates were not found to be significantly different in smoking compared to non-smoking patients with SLActive implants.
Conclusion
This 510(k) does not intend to introduce new implants neither to modify cleared implants design. The documentation submitted in this premarket notification demonstrates the Straumann® SLActive® labeling changes are substantially equivalent to the primary predicate and reference devices.
References:
Alsahhaf A, Alshagroud RS, Al-Aali KA, Alofi RS, Vohra F, Abduljabbar T. Survival of Titanium-Zirconium and Titanium Dental Implants in Cigarette-smokers and Never-smokers: A 5-Year Follow-up. Chin J Dent Res. 2019;22(4):265-272. doi: 10.3290/j.cjdr.a43737. PMID: 31859286.
Xiao W, Chen Y, Chu C, Dard MM, Man Y. Influence of implant location on titanium-zirconium alloy narrow-diameter implants: A 1-year prospective study in smoking and nonsmoking populations. J Prosthet Dent. 2022 Aug;128(2):159-166. doi: 10.1016/i.prosdent.2020.09.051. Epub 2021 Feb 5. PMID: 33551139.
Chen Y, Man Y, Clinical Evaluation of SLActive Titanium-zirconium narrow diameter implants for anterior and posterior crowns in smokers and non-smokers group. In proceedings from ITT World Symposium, 4-6 May 2017, Basel, Switzerland, Abstract 045