(142 days)
K120414 OsseoSpeed™ Plus, K130808 Straumann Healing Abutments, Healing Caps, and Closure Screws, K092814 Straumann NC Temporary Abutments, K120822 Straumann CARES Variobase Abutments, K142890 Straumann Variobase Abutments, K150203 Medentika CAD/CAM Abutments, K150899 Straumann CARES TAN Abutments, K062129 P.004 Implants
No
The document describes dental implants and related components, with no mention of AI or ML technology in the intended use, device description, or performance studies. The software mentioned is for CAD/CAM design, which is not inherently AI/ML.
Yes
The input text describes various components for dental implants and prosthetic rehabilitations, all of which are designed to restore missing teeth and improve oral function, aligning with the definition of a therapeutic device.
No
The device description and intended use indicate that the Straumann® Bone Level Tapered Implants and associated components are for oral endosteal implantation and rehabilitation of missing teeth, not for diagnosing medical conditions.
No
The device description clearly outlines various hardware components including implants, closure caps, healing abutments, temporary abutments, and Variobase and CARES abutments, all made from physical materials like Titanium and TAN. While software is mentioned for design purposes, the core of the device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for oral endosteal implantation and the functional and aesthetic oral rehabilitation of patients with missing teeth. This involves surgical placement and mechanical support for dental prosthetics.
- Device Description: The device description details the physical components of dental implants and abutments, their materials, and their function in supporting dental restorations.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are specifically designed to perform tests on biological samples to gain diagnostic information. This device is a medical device used for surgical and prosthetic purposes within the body.
N/A
Intended Use / Indications for Use
Straumann® Ø2.9 mm Bone Level Tapered Implants, SC Closure Cap, SC Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutments
Straumann® Bone Level Tapered Implants Ø2.9 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 02,9 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 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 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw.
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant comection.
Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Strauman® SC Temporary Abutments have a maximum duration of usage of 180 days.
Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Straumann Ø2.9mm Bone Level Tapered (BLT) Implants are apically tapered implants with an external diameter of Ø2.9 mm and lengths of 10 mm, 12 mm, and 14 mm. The implants are manufactured utilizing the Roxolid material and are finished with either the SLA® or SLActive® surface. The prosthetic platform is identified as SC (Small CrossFit®) which corresponds to a shoulder diameter of Ø2.9 mm.
The closure cap and healing abutments are manufactured from Titanium Grade 4 and are anodized blue for identification purposes. The closure cap is conical and has a height of 0.5 mm. The healing abutments are seated in the implant with a basal screw which is manufactured from TAN. The healing abutments are oval in shape and are available in four different heights ranging between 2.0 mm and 6.5 mm.
The temporary abutments are manufactured from TAN and are anodized blue for identification purposes. The temporary abutments are oval in shape in order to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The temporary abutments are seated in the implant with a basal screw which is also manufactured from TAN.
There are three components to the Straumann® SC Variobase™ Abutments:
- Straumann® SC Variobase™ Abutments (Ti-base)
- Prosthetic restoration (coping and/or crown)
- Basal Screw
The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.
The following is an overview of the possible prosthetic restoration (coping and/or crown) materials:
- Cast materials:
- Type 4 metals (ISO 22674)
- Base metal alloys (e.g., cobalt-chromium (CoCr))
- Noble metal alloys (e.g., gold alloy)
- Press materials:
- IPS e.max® Press Ceramic (K120053)
- Digital materials:
- coron®
- zerion® LT
- polycon® ae
All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann® SC CARES® Abutments are customized abutments manufactured from TAN. The abutments are designed by the customer by scanning the intraoral situation and designing of the shape with the CAD module of the integrated software. The design data is then sent to Straumann where the fabrication of the customized abutment is performed. The TAN alloy is capable of being directly veneered once the abutment is subject to a heat treatment step by the dental laboratory technician. A finished crown may also be cemented to the subject abutments rather than by direct veneer. The abutments will be delivered with the corresponding basal screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw
Indicated Patient Age Range
Not Found
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)
Performance data provided in support of substantial equivalence determination include:
- Sterilization Validation: The sterilization process for SC Temporary Abutments, SC Variobase Abutments, and SC CARES Abutments was validated according to FDA guidance.
- Biocompatibility Testing: No additional biocompatibility testing was required as the subject devices have identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to predicate devices, and raise no new biocompatibility issues.
- Software Verification and Validation Testing: Software verification and validation testing were conducted according to FDA guidance documents. The software for this device was considered a "moderate" level of concern.
- Bench Testing: Dynamic fatigue, static strength, and insertion torque tests were conducted according to FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the devices are equivalent to the predicate and reference devices.
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.
K140878 – Straumann Bone Level Tapered Implant
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.
K120414 OsseoSpeed™ Plus, K130808 Straumann Healing Abutments, Healing Caps, and Closure Screws, K092814 Straumann NC Temporary Abutments, K120822 Straumann CARES Variobase Abutments, K142890 Straumann Variobase Abutments, K150203 Medentika CAD/CAM Abutments, K150899 Straumann CARES TAN Abutments, K062129 P.004 Implants
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping silhouettes. The silhouettes are arranged to suggest a sense of movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2017
Straumann USA, LLC % Jennifer Jackson Director, Regulatory Affairs & Quality 60 Minuteman Road Andover, Massachusetts 01810
Re: K162890
Trade/Device Name: Straumann Ø2.9 mm Bone Level Tapered Implants, SC Closure Cap. SC Healing Abutments, SC Temporary Abutments, SC Variobase Abutments. SC CARES Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 16, 2017 Received: February 17, 2017
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Straumann® Ø2.9 mm Bone Level Tapered Implants, SC Closure Cap, SC Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutments
Indications for Use (Describe)
Straumann® Bone Level Tapered Implants Ø2.9 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 02,9 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 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 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw.
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant comection.
Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Strauman® SC Temporary Abutments have a maximum duration of usage of 180 days.
Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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4
Straumann® Ø2.9 mm Bone Level Tapered Implants
510(k) Summary
510(k) Summary 5
Submitter's Contact Information 5.1
Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
| Phone Number: | 1-978-747-2509 |
|---|---|
| --------------- | ---------------- |
Fax Number: 1-978-747-0023
Contact Person: Jennifer M. Jackson, MS
Date of Submission: March 6, 2017
5.2 Name of the Device
| Trade Names: | Straumann® Ø2.9 mm Bone Level Tapered Implants | |
|---|---|---|
| SC Closure Cap | ||
| SC Healing Abutments | ||
| SC Temporary Abutments | ||
| SC Variobase® Abutments | ||
| SC CARES® Abutments | ||
| Common Name: | Endosseous Dental Implant | |
| Endosseous Dental Implant Abutment | ||
| Classification Name: | Endosseous Dental Implant | |
| Regulation Number: | §872.3640 | |
| Classification: | Class II | |
| Product Codes: | DZE, NHA |
5.3 Predicate Device(s)
Primary Predicate:
K140878 – Straumann Bone Level Tapered Implant
5
Straumann® Ø2.9 mm Bone Level Tapered Implants
510(k) Summary
Reference Devices:
- K120414 OsseoSpeed™ Plus
- K130808 Straumann Healing Abutments, Healing Caps, and Closure Screws
- K092814 Straumann NC Temporary Abutments
- K120822 Straumann CARES Variobase Abutments
- K142890 Straumann Variobase Abutments
- K150203 Medentika CAD/CAM Abutments
- K150899 Straumann CARES TAN Abutments
- K062129 P.004 Implants
5.4 Device Description
The Straumann Ø2.9mm Bone Level Tapered (BLT) Implants are apically tapered implants with an external diameter of Ø2.9 mm and lengths of 10 mm, 12 mm, and 14 mm. The implants are manufactured utilizing the Roxolid material and are finished with either the SLA® or SLActive® surface. The prosthetic platform is identified as SC (Small CrossFit®) which corresponds to a shoulder diameter of Ø2.9 mm.
The closure cap and healing abutments are manufactured from Titanium Grade 4 and are anodized blue for identification purposes. The closure cap is conical and has a height of 0.5 mm. The healing abutments are seated in the implant with a basal screw which is manufactured from TAN. The healing abutments are oval in shape and are available in four different heights ranging between 2.0 mm and 6.5 mm.
The temporary abutments are manufactured from TAN and are anodized blue for identification purposes. The temporary abutments are oval in shape in order to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The temporary abutments are seated in the implant with a basal screw which is also manufactured from TAN.
There are three components to the Straumann® SC Variobase™ Abutments:
- Straumann® SC Variobase™ Abutments (Ti-base) ●
- Prosthetic restoration (coping and/or crown) .
- Basal Screw .
6
Straumann® Ø2.9 mm Bone Level Tapered Implants
510(k) Summary
The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.
The following is an overview of the possible prosthetic restoration (coping and/or crown) materials:
- Cast materials: .
- o Type 4 metals (ISO 22674)
- Base metal alloys (e.g., cobalt-chromium (CoCr)) o
- Noble metal alloys (e.g., gold alloy) o
- Press materials: ●
- o IPS e.max® Press Ceramic (K120053)
- . Digital materials:
- o coron®
- o zerion® LT
- o polycon® ae
All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann® SC CARES® Abutments are customized abutments manufactured from TAN. The abutments are designed by the customer by scanning the intraoral situation and designing of the shape with the CAD module of the integrated software. The design data is then sent to Straumann where the fabrication of the customized abutment is performed. The TAN alloy is capable of being directly veneered once the abutment is subject to a heat treatment step by the dental laboratory technician. A finished crown may also be cemented to the subject abutments rather than by direct veneer. The abutments will be delivered with the corresponding basal screw.
7
Straumann® Ø2.9 mm Bone Level Tapered Implants
510(k) Summary
5.5 Intended Use
The Straumann dental Implants are intended for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of patients with missing teeth.
Closure Caps and Healing Abutments are intended for use with the Straumann® Bone Level Tapered Implants Ø2.9 mm to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.
Straumann® SC Temporary Abutments are intended to be placed into Straumann dental implants to provide support for temporary crowns and bridges.
Straumann® SC Variobase® Abutments are intended to be placed into Straumann® Bone Level Tapered Implants Ø2.9 mm to provide support for individual crowns or bridges. Straumann® SC CARES® abutments are intended for use as an aid in prosthetic rehabilitation.
5.6 Indications for Use
Straumann® Bone Level Tapered Implants ø2.9 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 ø2.9 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 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 ø2.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw.
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant connection.
8
Straumann® Ø2.9 mm Bone Level Tapered Implants
510(k) Summary
Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Straumann® SC Temporary Abutments have a maximum duration of usage of 180 days. Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
5.7 Technological Characteristics
5.7.1 Straumann® Ø2.9 mm Bone Level Tapered Implants
The technological principles are the same for the subject and primary predicate devices. Both the subject device and primary predicate device 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. The subject devices are specifically indicated for the lateral incisor in the upper jaw and the lower incisors. The indications for use for the subject devices are within the scope of the indications for use for the primary predicate device. The narrower indications do not change the intended use. The main differences in the technological characteristics between the subject device and the primary predicate device are the implant diameter (Ø2.9 mm vs. Ø3.3, Ø 4.1 and Ø 4.8 mm) and the implant to abutment connection (Small CrossFit® (SC) versus Narrow CrossFit® (NC) and Regular CrossFit® (RC)). The technological characteristics of the subject devices are compared to the primary and reference predicate in Table 1.
9
Straumann® Ø2.9 mm Bone Level Tapered Implants
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE
PREDICATE DEVICE |
|--------------------------------------|-------------------------------------------|-------------------------------------------------|----------------------------------------|
| K Number | Subject Device | K140878 | K120414 |
| Material | Titanium-13 Zirconium
alloy (Roxolid®) | Titanium-13 Zirconium
alloy (Roxolid®) | Commercially pure
titanium, grade 4 |
| Surface
Treatment | SLA® and SLActive® | SLA® and SLActive® | OsseoSpeed™ |
| Implant to
Abutment
Connection | Small CrossFit® (SC) | Narrow CrossFit® (NC)
Regular CrossFit® (RC) | Six position connection |
| Implant
Diameter | Ø2.9 mm | Ø3.3, Ø4.1, and Ø4.8 mm | Ø3.0 mm |
| Implant Length | 10, 12, and 14 mm | 8, 10, 12, and 14 mm | 8, 9, 11, 13, and 15 mm |
| Implant Design | Straight implant with apical
taper | Straight implant with apical
taper | Straight implant with apical
taper |
510(k) Summary
Table 1 – Comparison of subject device versus primary and reference predicate devices (Dental Implants)
5.7.2 Straumann® Closure Cap and Healing Abutments
The technological principles and intended use are identical for the subject and reference predicate devices. The intended use is to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The main differences in the technological characteristics between the subject and reference predicate devices are the shape and diameter of the devices. The subject devices are dimensionally smaller to accommodate the smaller diameter implant. The technological characteristics of the subject devices are compared to the reference predicate in Table 2.
10
Straumann® Ø2.9 mm Bone Level Tapered Implants
| FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE
DEVICE |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| K Number | Subject Device | K130808 |
| Material | Titanium Grade 4
Ti-6Al-7Nb (Basal Screws) | Titanium Grade 4 |
| Implant to
Abutment
Connection | Small CrossFit® (SC) | Narrow CrossFit® (NC) |
| Diameter or
Minor Oval
Dimension/
Major Oval
Dimension | Closure Cap:
Ø2.4 mm
Healing Abutments:
3.3/4.3 mm
3.55/4.86 mm
3.6/5.0 mm | Closure Cap:
Ø2.77 and Ø3.05 mm
Healing Abutment:
Ø3.6 |
| Overall Length | Closure Cap:
5.8 mm
Healing Abutment (including basal screw):
7.0, 8.5, 10.0, 11.5 mm | Closure Cap:
6.25 and 6.8 mm
Healing Abutment:
8.1, 9.6, 11.1 mm |
| Gingival Heights | Closure Cap:
0.5 mm
Healing Abutments:
2.0, 3.5, 5.0 and 6.5 mm | Closure Cap:
0 mm and 0.5 mm
Healing Abutments:
2.0, 3.5, and 5.0 mm |
510(k) Summary
Table 2 – Comparison of subject device versus reference device (SC Closure Cap and SC Healing Abutments)
Temporary Abutments 5.7.3
The technological principles and intended use are identical for the subject and reference predicate devices. The devices are intended to be placed into Straumann dental implants to provide support for temporary crowns and bridges. The main differences in the technological characteristics between the subject and reference predicate devices are the shape and diameter of the devices. The subject devices are dimensionally smaller to accommodate the smaller diameter implant. The technological characteristics of the subject devices are compared to the reference predicate in Table 3.
11
Straumann® Ø2.9 mm Bone Level Tapered Implants
| FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE |
|---|---|---|
| K Number | Subject Device | K092814 |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb |
| Implant to | ||
| Abutment | ||
| Connection | Small CrossFit® (SC) | Narrow CrossFit® (NC) |
| Diameter or | ||
| Minor Oval | ||
| Dimension/ | ||
| Major Oval | ||
| Dimension | 3.3/4.3 mm | Ø3.5 mm |
| Overall Length | 13.2, 14.2, and 15.2 mm | 13.75 mm |
| Gingival Heights | 1.0, 2.0, and 3.0 mm | 1.0 mm |
510(k) Summary
Table 3 - Comparison of subject device versus reference predicate device (SC Temporary Abutments)
5.7.4 SC Variobase® Abutments
The technological principles and intended use are identical for the subject and reference predicate devices. The devices are intended to be placed into dental implants to provide support for individual crowns or bridges. The subject devices are specifically indicated for the lateral incisor in the upper jaw and the lower incisors. The indications for use for the subject devices are within the scope of the indications for use for the reference predicate devices. The narrower indications do not change the intended use.
The main differences in the technological characteristics between the subject and reference predicate devices are the shape and diameter of the devices. The subject devices are dimensionally smaller to accommodate the smaller diameter of the implant. The subject devices also have only two retention features compared to the Straumann reference predicate device which has four retention features. The Medentika reference predicate has one retention feature. The technological characteristics of the subject devices are compared to the reference predicate in Table 4.
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Straumann® Ø2.9 mm Bone Level Tapered Implants
| FEATURE | PROPOSED DEVICE | REFERENCE
PREDICATE DEVICES | REFERENCE
PREDICATE DEVICES |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| K Number | Subject Device | K142890/K120822 | K150203
R Series |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-4V |
| Implant to Abutment
Connection | Small CrossFit® (SC) | Narrow CrossFit® (NC)
Regular CrossFit® (RC)
Narrow Neck CrossFit®
(NNC)
Regular Neck (RN)
Wide Neck (WN) | 2.5mmD Internal
Hexagon |
| Diameter or Minor
Oval Dimension/
Major Oval
Dimension | 3.3/4.3 mm | Ø3.8 - 7.0 mm | Ø3.5 – 5.7 mm |
| Overall Abutment
Height | 6.7 – 8.7 mm | 5.9 – 8.9 mm | 6.15 – 7.54 mm |
| Coping/ Crown
Material | Traditional Workflow:
Type 4 metals (ISO
22674)
IPS e.max® Press
Ceramic
Digital Workflow:
coron® (permanent)
zerion® LT (permanent)
polycon® ae (temporary) | Traditional Workflow:
Type 4 metals (ISO
22674)
IPS e.max® Press
Ceramic
Digital Workflow:
IPS e.max® CAD
Ceramic (permanent)
coron® (permanent)
zerion® (permanent)
polycon® ae (temporary) | Digital Workflow:
zerion® (permanent) |
| Design Workflow | Wax-up or Open CAD | Wax-up or Open CAD
CARES® Visual | CARES® Visual |
| Manufacturing
Workflow | Traditional casting or
pressing
or
Straumann Milling | Traditional casting or
pressing
or
Straumann Milling | Straumann Milling |
| Mode of Action | Screw-retained or
cement retained | Screw-retained or
cement retained | Screw-retained or
cement retained |
510(k) Summary
Table 4 - Comparison of subject device versus reference device (SC Variobase Abutments)
5.7.5 SC CARES® Abutments
The technological principles and intended use are identical for the subject and reference predicate devices. The devices are intended for use as an aid in prosthetic rehabilitation. The main differences in the technological characteristics between the subject and reference predicate devices are the diameter and the dimension for the abutment to implant connection. The technological characteristics of the subject devices are compared to the reference predicate in Table 5.
13
Straumann® Ø2.9 mm Bone Level Tapered Implants
510(k) Summary
| FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE |
|---|---|---|
| K Number | Subject Device | K150899 |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb |
| Implant to | ||
| Abutment | ||
| Connection | Small CrossFit® (SC) | Narrow CrossFit® (NC) |
| Abutment | ||
| coronal design | CADCAM design process. | |
| Designs controlled by material-specific | ||
| design limits in the CARES Visual CAD | ||
| software, model verification performed by | ||
| the CAM software and milling blank | ||
| dimensions used by the Straumann | ||
| milling center. | CADCAM design process. | |
| Designs controlled by material-specific | ||
| design limits in the CARES Visual CAD | ||
| software, model verification performed by | ||
| the CAM software and milling blank | ||
| dimensions used by the Straumann | ||
| milling center. | ||
| CAD Design | ||
| Limits | Maximum Angulation 30° | Maximum Angulation 30° |
| Emergence Offset 0.1 mm | Emergence Offset 0.1 mm | |
| Emergence Angle 65° | Emergence Angle 65° | |
| Minimum Thickness 0.4 mm | Minimum Thickness 0.4 mm | |
| Smooth Distance 0.5 mm | Smooth Distance 0.5 mm | |
| Coping/ Crown | Cemented | Cemented |
| Directly veneerable | Directly veneerable |
Table 5 - Comparison of subject device versus reference device (SC CARES Abutments)
5.8 Performance Testing
The following performance data were provided in support of the substantial equivalence determination.
Sterilization Validation 5.8.1
The sterilization process for the SC Temporary Abutments, SC Variobase Abutments, and SC CARES Abutments as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
5.8.2 Biocompatibility Testing
Table 32ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according 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
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Straumann® Ø2.9 mm Bone Level Tapered Implants
510(k) Summary
Administration Staff, Document issued on: June 16, 2016" for each of the subject devices.
The subject devices have the identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to the primary and reference predicate devices. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.
5.8.3 Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided according to the FDA guidance documents "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". The software for this device was considered as a "moderate" level of concern as a failure in the Straumann CARES Visual software could result in a non-fitting or poor-fitting restoration or framework.
5.8.4 Bench Testing
Dynamic fatigue, static strength, and insertion torque tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Straumann® Ø2.9 mm Bone Level Tapered implants, SC Temporary Abutments, SC Variobase Abutments, and SC CARES abutments are equivalent to the predicate and reference devices.
5.9 Conclusion
The documentation submitted in this premarket notification demonstrates the Straumann® Ø2.9 mm Bone Level Tapered implants, SC Closure Caps and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, and SC CARES Abutments are substantially equivalent to the primary predicate and reference devices.