Straumann SLActive labeling changes

• K Number: K223083
• Device Name: Straumann SLActive labeling changes
• Manufacturer: Institut Straumann AG
• Date Cleared: 2023-06-22 ( 265 days)
• Product Code: DZE
• Regulation Number: 872.3640
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: K083550 , K111357 , K121131 , K122855 , K140878 , K153758 , K162890 , K173961 , K181703 , K191256 , K200586 , K202942 , K210855 , K212533 , K123784 , K171784
• Predicate For: N/A

Intended Use

Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

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.

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

AI/ML Overview

The device being discussed is "Straumann® SLActive® labeling changes" (K223083). This 510(k) pertains to labeling changes for existing Straumann® SLActive® dental implants and does not introduce new implants or modify existing implant designs. The primary predicate device is K171784 – Straumann Dental Implant System, with several other Straumann® implant systems listed as reference devices.

The acceptance criteria and supporting study are primarily focused on substantiating the updated labeling, particularly regarding the use of SLActive implants in smokers and general wording clarifications.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Evaluation by FDA)	Reported Device Performance (Summary from Submission)
For General Labeling Changes (Changes to Indications for Use wording): Demonstrated substantial equivalence to predicate devices, ensuring that differences in wording do not alter the application, safety, or effectiveness of the devices.	The provided comparative tables for Indications for Use (Table 2) show that the proposed wording is Equivalent to the primary and reference predicate devices. - All indications continue to allow for implant placement in the jaw, providing support for single-tooth or multiple-tooth restorations, and allowing for immediate loading when good primary stability is achieved. - Information regarding prosthetic restorations was not excluded but relocated to the device description for better understanding. - The requirement for "4 or more implants for fully edentulous patients" was removed from indications for use as it is considered "common knowledge." - New specific Indications for Use for Ø 3.3 mm implants provide more details. - The "Precaution" section of the Instructions for Use now addresses the use of narrow implants in the molar region. - For specific implant types (e.g., BLX implants), the single-tooth restoration was considered the "worst case due to the higher masticatory load," indicating an understanding of potential stress.
For "Smokers' Claim" (Outcomes of SLActive implants in smokers are encouraging): Supported by clinical evidence demonstrating that implant performance (e.g., failure rates, adverse events) is not significantly worse in smokers compared to non-smokers with SLActive implants. Demonstrated through systematic literature review or clinical studies.	A systematic literature search identified 5 publications. - 251 SLActive implants were placed in 237 patients (age range 25-65 years old). - Studies included titanium or titanium-zirconium alloy implants with SLActive surfaces, diameters 3.3-4.8 mm, and lengths 8-12 mm. - Reported adverse events (failure to osseointegrate, peri-implantitis, spinning/mobility during surgery, late failure, bone loss, abutment loosening, paresthesia, acrylic/porcelain chipping) were not reported at a higher rate in smokers compared to non-smokers. - Implant failure rates were not found to be significantly different in smoking compared to non-smoking patients with SLActive implants. - References: Alsahhaf A (2019), Xiao W (2021), Chen Y (2017), Sener T (2010), Luongo G (2016). (Note: Sener and Luongo were cited in the text but not fully listed in the provided references section).
Sterility: Sterilization process validated to SAL of 10^-6. Meets pyrogen limit specifications.	- Sterilization via gamma irradiation after final packaging. - Validated to a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137-1 and ISO 11137-2 (VDmax25 method). - Pyrogen limit specifications met with LAL Endotoxin Analysis, testing limit of 20 EU/device (per FDA Guidance and ISO 10993-1).
Biocompatibility: Biological assessment performed according to ISO 10993-1 and FDA Guidance.	- Biological assessment performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1..." for each device. (Results are not detailed but the assessment was stated to be performed).
Dynamic Fatigue: Assessment conducted per FDA guidance and ISO 14801.	- Dynamic fatigue assessment conducted according to FDA guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. - Test covers permanent restoration of implants without failure. (Results are not detailed but the assessment was stated to be performed).
Insertion Performance: Demonstrated adequate insertion torque in different bone classes.	- Insertion tests performed for the subject implants. - Showed adequate insertion torque in different bone classes when inserted according to the surgical procedure. (Results are not detailed but the assessment was stated to be performed).
MR Safety: Evaluated for MR Conditional status.	- Obtained MR Conditional status per K180540. - MR Conditional tests conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment." (Results are not detailed but the status was noted).

2. Sample Size Used for the Test Set and Data Provenance

The core of the "study" for the labeling changes, especially concerning the "smokers' claim," was a systematic literature review, not a direct clinical trial conducted by the applicant for this 510(k).

• Sample Size for Smokers' Claim: The literature review included data from 5 publications which collectively involved 251 SLActive implants placed in 237 patients.
• Data Provenance: The data came from published clinical studies. The document does not specify the exact country of origin for all studies, but at least two cited papers involve authors from China (Xiao, Chen), one from Saudi Arabia (Alsahhaf), and the ITT World Symposium (Chen 2017) was held in Switzerland. The studies are explicitly described as "clinical studies," implying they were prospective or retrospective clinical investigations.

For other non-clinical performance characteristics (sterility, biocompatibility, dynamic fatigue, insertion tests, MR safety), these appear to be internal bench tests and assessments conducted by the manufacturer, or previously established for the cleared predicate/reference devices. No specific sample sizes for these tests are provided in this summary, but it's stated that "No significant changes have been performed to the subject implants since clearance so previously cleared bench data continue to be representative."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• For the "smokers' claim" (literature review): The "ground truth" (i.e., the reported outcomes like adverse event rates and implant failure rates) was established by the authors of the original 5 clinical publications. The document does not specify the qualifications of these individual authors. However, given they are "published clinical studies," it's understood that dental/medical professionals (e.g., oral surgeons, periodontists, implantologists) would have conducted these studies and reported the outcomes.
• For the equivalence discussion of Indications for Use: The "ground truth" is established by comparing the proposed wording against the previously cleared wording in the primary and reference predicate devices, which were approved by the FDA based on clinical and scientific evidence at the time of their clearance. This comparison itself is performed by regulatory affairs experts on behalf of the manufacturer.

4. Adjudication Method for the Test Set

• For the "smokers' claim" (literature review): The adjudication of adverse events and implant failure rates was performed within each of the original 5 clinical studies. The specific adjudication methods used in those individual studies are not detailed in this 510(k) summary. Given the nature of scientific literature, these studies would typically involve clinical follow-up and assessment by the treating clinicians/researchers.
• For the Indications for Use equivalence: This is a comparison process, not a clinical adjudication. The equivalence of wording is assessed by regulatory experts against the historical FDA clearances.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was NOT done. This submission is for labeling changes for dental implants, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Not applicable. This submission is for a medical device (dental implants), not a software algorithm or AI.

7. The Type of Ground Truth Used

• For the "smokers' claim": The ground truth was clinical outcomes data reported in peer-reviewed published clinical studies. These outcomes included adverse events (e.g., failure to osseointegrate, peri-implantitis, bone loss) and implant failure rates.
• For other performance tests (sterility, fatigue, etc.): The ground truth would be established through defined bench testing protocols and adherence to international standards (e.g., ISO, FDA guidance).

8. The Sample Size for the Training Set

• Not applicable. This submission is not for a machine learning or AI device that requires a training set. The "smokers' claim" was based on a literature review which leverages existing published clinical data, akin to an external validation set rather than a training set for the current submission.

9. How the Ground Truth for the Training Set was Established

• Not applicable. (See point 8.)

Summary

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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.

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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 ([e-mail]) or phone [phone] 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

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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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Straumann® SLActive® Labeling Changes

510(k) Summary

510(k) Summary

Submitter's Contact Information

Submitter:	Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
	On the behalf of: Institut Straumann AG
	Institut Straumann AGPeter Merian-Weg 124052 Basel, Switzerland.
Contact Person:	Jennifer M. Jackson, MS, RACSr. Director, Regulatory Affairs and QualityPhone Number: [phone]Fax Number: [phone]
Prepared By:	Camila da Silva EstevesExternal 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®

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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

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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.

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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).

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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 PREDICATEDEVICE	REFERENCE PREDICATEDEVICES
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 alloyTitanium Grade 4	Titanium-Zirconium alloy
SurfaceTreatment	SLActive® - Hydrophilic, sandblasted, large grit, acid etched.	SLActive® - Hydrophilic, sandblasted, large grit, acid etched.
Implant toAbutmentConnection	TorcFit®CrossFit®SynOcta®	SynOcta®CrossFit®	TorcFit®CrossFit®SynOcta®
ImplantDiameter	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
ImplantLength	4, 6, 8, 10, 12, 14, 16 and18mm	6, 8, 10, 12, 14, 16 and 18mm	4, 6, 8, 10, 12, 14, 16 and18mm
ImplantDesign	Tissue level (parallel and fullytapered wall)Bone level (parallel, tapered andfully tapered wall)	Tissue level (parallel wall)Bone level (parallel and taperedwall)	Tissue level (parallel and fullytapered wall)Bone level (parallel, tapered andfully tapered wall)

Table 1 – Comparison of subject device versus primary predicate device

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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.

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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

KNUMBER	PROPOSED INDICATIONS FOR USE	PRIMARY PREDICATE DEVICEINDICATIONS FOR USE(K171784)	REFERENCE PREDICATE DEVICEINDICATIONS FOR USE	EQUIVALENCE DISCUSSION
K083550	IFU: 704333Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.Unless stated in specific indications, theyimplantation following the extraction orloss of natural teeth. The implants can beplaced with immediate function for single-tooth and/or multiple-tooth restorationswhen good primary stability is achievedand with appropriate occlusal loading torestore chewing function.Titanium Ø 3.3 mm implantsØ3.3 mm S and SP RN implants are to beused only for the following indications:Partially dentate jaws with implant-borne,fixed constructions: combine with a Ø4.1mm implants and splint thesuperstructure.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients.Straumann® Dental implants areindicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference predicate - K083550:Straumann® ROXOLID dental implants aresuitable for the treatment of oral endostealimplantation in the upper and lower jaw and forthe functional and aesthetic oral rehabilitation ofedentulous and partially dentate patients(unless specific indications and limitations arepresent, as stated below). Straumann®ROXOLID dental implants can also be used forimmediate or early implantation followingextraction or loss of natural teeth. Implants canbe placed with immediate function on single-tooth and/or multiple tooth applications whengood primary stability is achieved and withappropriate occlusal loading, to restorechewing functions. The prosthetic restorationsused are single crowns, bridges and partial orfull dentures, which are connected to theimplants by the corresponding elements(abutments). When placing implants in theposterior region we recommend using onlylarge diameter implants. In cases of fullyedentulous patients, 4 or more implants mustbe used in immediately loaded cases.Specific indications for small diameter (Ø3.3mm) implants:Because of their reduced mechanical stability,small diameter implants are only used in caseswith a low mechanical load. Placement in themolar region is not recommended.	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.The use of 4 or more implants forfully edentulous patients iscommon knowledge and wereremoved from the indications foruse.The new specific Indications forUse for Ø 3.3 mm implantsprovides more details on therecommended clinical procedure.Additionally, the sectionPrecaution of the IFU showbrings attention to the use inmolar region.

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Straumann® SLActive® Labeling Changes

KNUMBER	PROPOSED INDICATIONS FOR USE	PRIMARY PREDICATE DEVICEINDICATIONS FOR USE(K171784)	REFERENCE PREDICATE DEVICEINDICATIONS FOR USE	EQUIVALENCE DISCUSSION
K111357	IFU 704333Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.Unless stated in specific indications, theycan be used for immediate, early or lateimplantation following the extraction orloss of natural teeth. The implants can beplaced with immediate function for single-tooth and/or multiple-tooth restorationswhen good primary stability is achievedand with appropriate occlusal loading torestore chewing function.Titanium Ø 3.3 mm implantsØ3.3 mm S and SP RN implants are to beused only for the following indications:Partially dentate jaws with implant-borne,fixed constructions: combine with a Ø4.1mm implants and splint thesuperstructure.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K111357:Straumann® dental implants are suitable for thetreatment of oral endosteal implantation in theupper and lower jaw and for the functional andaesthetic oral rehabilitation of edentulous andpartially dentate patients. Straumann® dentalimplants can also be used for immediate orearly implantation following extraction or loss ofnatural teeth. Implants can be placed withimmediate function on single-tooth and/ormultiple tooth applications when good primarystability is achieved and with appropriateocclusal loading, to restore chewing function.The prosthetic restorations used are singlecrowns, bridges and partial or full dentures,which are connected to the implants by thecorresponding components (abutments). Whenplacing implants in the posterior region, werecommend using only large diameter implants.In cases of fully edentulous patients, 4 or moreimplants must be used in immediately loadedcases.Small Diameter Implants (Ø 3.3 mm)Because of their reduced mechanical stability,small diameter implants are only used in caseswith low mechanical load. Placement in themoral region is not recommended.	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.The use of 4 or more implantsfor fully edentulous patients iscommon knowledge and wereremoved from the indications foruse. The new specificIndications for Use for Ø 3.3 mmimplants provides more detailson the recommended clinicalprocedure. Additionally, thesection Precaution of the IFUshow brings attention to the usein molar region.

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Straumann® SLActive® Labeling Changes

KNUMBER	PROPOSED INDICATIONS FOR USE	PRIMARY PREDICATE DEVICEINDICATIONS FOR USE(K171784)	REFERENCE PREDICATE DEVICEINDICATIONS FOR USE	EQUIVALENCE DISCUSSION
K121131	IFU 704333Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.Unless stated in specific indications, theycan be used for immediate, early or lateimplantation following the extraction orloss of natural teeth. The implants can beplaced with immediate function for single-tooth and/or multiple-tooth restorationswhen good primary stability is achievedand with appropriate occlusal loading torestore chewing function.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K121131:The Straumann® dental implants are suitablefor the treatment of oral endosteal implantationin the upper and lower jaw and for the functionaland esthetic oral rehabilitation of edentulousand partially dentate patients (unless specificindications and limitations are specified).Straumann® dental implants can be used forimmediate or early implantation followingextraction or loss of natural teeth. Implants canbe placed with immediate function on single-tooth and/or multiple tooth applications whengood primary stability is achieved and withappropriate occlusal loading, to restorechewing function. The prosthetic restorationsare single crown, bridges and partial or fulldenture, which are connected to the implants bythe corresponding elements (abutments).When placing implants in the posterior region,we recommend using only large diameterimplants. In cases of fully edentulous patients,4 or more implants must be used in immediatelyloaded cases.	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.The use of 4 or more implants forfully edentulous patients iscommon knowledge and wereremoved from the indications foruse.

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Straumann® SLActive® Labeling Changes

KNUMBER	PROPOSED INDICATIONS FOR USE	PRIMARY PREDICATE DEVICEINDICATIONS FOR USE(K171784)	REFERENCE PREDICATE DEVICEINDICATIONS FOR USE	EQUIVALENCE DISCUSSION
K122855	IFU 704333Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.Unless stated in specific indications, theycan be used for immediate, early or lateimplantation following the extraction orloss of natural teeth. The implants can beplaced with immediate function for single-tooth and/or multiple-tooth restorationswhen good primary stability is achievedand with appropriate occlusal loading torestore chewing function.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K122855:Straumann® dental implants are suitable for thetreatment of oral endosteal implantation in theupper and lower jaw and for the functional andesthetic oral rehabilitation of edentulous andpartially dentate patients (unless specificimplants and limitations are present, as statedbelow). Straumann® dental implants can alsobe used for immediate or early implantationfollowing extraction or loss of natural teeth.Implants can be placed with immediate functionon single-tooth and/or multiple toothapplications when good primary stability isachieved and with appropriate occlusal loading,to restore chewing function. The prostheticrestorations used are single crowns, bridgesand partial or full dentures, which areconnected to the implants by correspondingelements (abutments). When placing implantsin the posterior region, we recommend usingonly larger diameter implants. In cases of fullyedentulous patients, 4 or more implants mustbe used in immediate loaded cases.	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.The use of 4 or more implants forfully edentulous patients iscommon knowledge and wereremoved from the indications foruse.

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Straumann® SLActive® Labeling Changes

KNUMBER	PROPOSED INDICATIONS FOR USE	PRIMARY PREDICATE DEVICEINDICATIONS FOR USE(K171784)	REFERENCE PREDICATE DEVICEINDICATIONS FOR USE	EQUIVALENCE DISCUSSION
K140878	IFU 704333Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.Unless stated in specific indications, theycan be used for immediate, early or lateimplantation following the extraction orloss of natural teeth. The implants can beplaced with immediate function for single-tooth and/or multiple-tooth restorationswhen good primary stability is achievedand with appropriate occlusal loading torestore chewing function.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K140878:Straumann® dental implants are indicated fororal endosteal implantation in the upper andlower jaw arches for the functional andaesthetic oral rehabilitation of edentulous andpartially dentate patients. Straumann® dentalimplants are also indicated for immediate orearly implantation following extraction or loss ofnatural teeth. Implants can be placed withimmediate function on single-tooth and/ormultiple tooth applications when good primarystability is achieved and with appropriateocclusal loading, to restore chewing function.The prosthetic restorations used are singlecrowns, bridges and partial or full dentures,which are connected to the implants throughthe corresponding components (abutments). Incases of fully edentulous patients, 4 or moreimplants must be used in immediately loadedcases.	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.The use of 4 or more implants forfully edentulous patients iscommon knowledge and wereremoved from the indications foruse.

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Straumann® SLActive® Labeling Changes

KNUMBER	PROPOSED INDICATIONS FOR USE	PRIMARY PREDICATE DEVICEINDICATIONS FOR USE(K171784)	REFERENCE PREDICATE DEVICEINDICATIONS FOR USE	EQUIVALENCE DISCUSSION
K153758	Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.Unless stated in specific indications, theycan be used for immediate, early or lateimplantation following the extraction orloss of natural teeth. The implants can beplaced with immediate function for single-tooth and/or multiple-tooth restorationswhen good primary stability is achievedand with appropriate occlusal loading torestore chewing function.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K153758Straumann® dental implants are indicated fororal endosteal implantation in the upper andlower jaw arches for the functional andaesthetic oral rehabilitation of edentulous andpartially dentate patients. Straumann® dentalimplants are also indicated for immediate orearly implantation following extraction or loss ofnatural teeth. Implants can be placed withimmediate function on single-tooth and/ormultiple tooth applications when good primarystability is achieved and with appropriateocclusal loading to restore chewing function.The prosthetic restorations used are singlecrowns, bridges and partial or full dentures,which are connected to the implants throughthe corresponding components (abutments).	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.The new specific Indications forUse for Ø3.3 mm implantsprovides more details on therecommended clinical procedure.Additionally, the sectionPrecaution of the IFU showbrings attention to the use inmolar region

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Straumann® SLActive® Labeling Changes

KNUMBER	PROPOSED INDICATIONS FOR USE	PRIMARY PREDICATE DEVICEINDICATIONS FOR USE(K171784)	REFERENCE PREDICATE DEVICEINDICATIONS FOR USE	EQUIVALENCE DISCUSSION
K162890	IFU 704333Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.Unless stated in specific indications, theycan be used for immediate, early or lateimplantation following the extraction orloss of natural teeth. The implants can beplaced with immediate function for single-tooth and/or multiple-tooth restorationswhen good primary stability is achievedand with appropriate occlusal loading torestore chewing function.Straumann® Roxolid® Bone LevelTapered Implant Ø 2.9 mmThe Straumann® Roxolid® Bone LevelTapered implants Ø 2.9 mm are indicatedfor single-unit reconstruction of incisorsin the lower jaw and lateral incisors in theupper jaw.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K162890Straumann® Bone Level Tapered ImplantsØ 2.9 mm are indicated for oral endostealimplantation in the upper and lower jaw and forthe functional and aesthetic oral rehabilitation ofpatients with missing teeth. Straumann® BoneLevel Tapered Implants Ø 2.9 mm can also beused for immediate or early implantationfollowing extraction or loss of natural teeth.Implants can be placed with immediate functionon single-tooth and/or multiple toothapplications when good primary stability isachieved and with appropriate occlusal loadingto restore chewing function. The prostheticrestorations are connected to the implantsthrough the corresponding components(abutments).The Straumann® Bone Level Tapered ImplantsØ 2.9 mm are indicated for reconstruction ofmissing incisors in the lower jaw and lateralincisors in the upper jaw.	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.The specific indications for Ø 2.9mm implants are the same as thereference device.
KNUMBER	PROPOSED INDICATIONS FOR USE	PRIMARY PREDICATE DEVICEINDICATIONS FOR USE(K171784)	REFERENCE PREDICATE DEVICEINDICATIONS FOR USE	EQUIVALENCE DISCUSSION
K173961	IFU 702110Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.They can be used for immediate, early orlate implantation following the extractionor loss of natural teeth. The implants canbe placed with immediate function forsingle-tooth and/or multiple-toothrestorations when good primary stabilityis achieved and with appropriate occlusalloading to restore chewing function.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K173961Straumann® BLX Implants are suitable forendosteal implantation in the upper and lowerjaw and for the functional and esthetic oralrehabilitation of edentulous and partiallyedentulous patients. BLX Implants can beplaced with immediate function on single-toothapplications when good primary stability isachieved and with appropriate occlusal loadingto restore chewing function. The prostheticrestorations are connected to the implantsthrough the corresponding abutmentcomponents.	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The single-tooth restorationwould be the worst case due tothe higher masticatory load.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.
K181703	IFU 702110Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.They can be used for immediate, early orlate implantation following the extractionor loss of natural teeth. The implants canbe placed with immediate function forsingle-tooth and/or multiple-toothrestorations when good primary stabilityis achieved and with appropriate occlusalloading to restore chewing function.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K181703Straumann® BLX Implants are suitable forendosteal implantation in the upper and lowerjaw and for the functional and esthetic oralrehabilitation of edentulous and partiallyedentulous patients. BLX Implants can beplaced with immediate function on single-tooth,bar and bridge applications when good primarystability is achieved and with appropriateocclusal loading to restore chewing function.The prosthetic restorations are connected tothe implants through the correspondingabutment components.	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The single-tooth restorationwould be the worst case due tothe higher masticatory load.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.
KNUMBER	PROPOSED INDICATIONS FOR USE	PRIMARY PREDICATE DEVICEINDICATIONS FOR USE(K171784)	REFERENCE PREDICATE DEVICEINDICATIONS FOR USE	EQUIVALENCE DISCUSSION
K191256	IFU 702110Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.They can be used for immediate, early orlate implantation following the extractionor loss of natural teeth. The implants canbe placed with immediate function forsingle-tooth and/or multiple-toothrestorations when good primary stabilityis achieved and with appropriate occlusalloading to restore chewing function.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K191256Straumann® BLX Implants are suitable forendosteal implantation in the upper and lowerjaw and for the functional and esthetic oralrehabilitation of edentulous and partiallyedentulous patients. BLX Implants can beplaced with immediate function on single-tooth,bar and bridge applications when good primarystability is achieved and with appropriateocclusal loading to restore chewing function.The prosthetic restorations are connected tothe implants by the corresponding abutmentcomponents.	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The single-tooth restorationwould be the worst case due tothe higher masticatory load.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.

{17}------------------------------------------------

Straumann® SLActive® Labeling Changes

{18}------------------------------------------------

Straumann® SLActive® Labeling Changes

{19}------------------------------------------------

Straumann® SLActive® Labeling Changes

KNUMBER	PROPOSED INDICATIONS FOR USE	PRIMARY PREDICATE DEVICEINDICATIONS FOR USE(K171784)	REFERENCE PREDICATE DEVICEINDICATIONS FOR USE	EQUIVALENCE DISCUSSION
K200586	IFU 704450Straumann® dental implants areindicated for the functional and estheticoral rehabilitation of the upper or lowerjaw of edentulous or partially edentulouspatients. They can be used forimmediate, early or late implantationfollowing the extraction or loss of naturalteeth. The implants can be placed withimmediate function for single-toothand/or multiple-tooth restorations whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K200586Straumann® TLX Implants are suitable forendosteal implantation in the upper and lowerjaws and for the functional and esthetic oralrehabilitation of edentulous and partiallyedentulous patients. TLX Implants can beplaced with immediate function on single-toothand multi-unit restorations when good primarystability is achieved and with appropriateocclusal loading to restore chewing function.The prosthetic restorations are connected tothe implants through the correspondingabutment components.	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth onmultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.
K202942	IFU 704333Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.Unless stated in specific indications, theycan be used for immediate, early or lateimplantation following the extraction orloss of natural teeth. The implants can beplaced with immediate function for single-tooth and/or multiple-tooth restorationswhen good primary stability is achievedand with appropriate occlusal loading torestore chewing function.Straumann® Roxolid® Standard Plus4 mm Short ImplantsStraumann® Roxolid® Standard Plus 4mm Short Implants are indicated for fixedor removable reconstruction in situationsof moderate to severely atrophic jawbonewith adequate bone quality that allowsprimary stability after implant insertion,where a longer implant cannot be placeddue to limited vertical bone height. Therecommended healing time beforeloading is between 10 to 12 weeks.Straumann® Roxolid® Standard Plus 4mm Short Implants are specificallyindicated or:• Fixed dentureprosthesis/splinted units (oneimplant per unit).• Pontic cases in combination withat least one longer implant.• Fully edentulous cases with atleast two Straumann® Roxolid®Standard Plus 4 mm ShortImplants in combination with 2longer implants in the anteriorregion.	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K202942Straumann® 4 mm Short Implants are indicatedfor fixed or removable reconstruction insituations of moderate to severely atrophicjawbone with adequate bone quality that allowsprimary stability after implant insertion, where alonger implant cannot be placed due to limitedvertical bone height. The recommended healingtime before loading is between 10 to 12 weeks.The 4 mm Short Implants are specificallyrecommended for:• Fixed denture prosthesis/splinted units(one implant per unit).• Pontic cases in combination with atleast one longer implant.• Fully edentulous cases with at least one4 mm Short Implant in combination with2 longer implants in the anterior regionand at least four total implants.	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.The specific indication for 4mmShort implants is the same as thereference predicate.
K210855	IFU 702110	Straumann® Dental implants areindicated for oral endosteal	Reference Predicate - K210855	Equivalent
KNUMBER	PROPOSED INDICATIONS FOR USE	PRIMARY PREDICATE DEVICEINDICATIONS FOR USE(K171784)	REFERENCE PREDICATE DEVICEINDICATIONS FOR USE	EQUIVALENCE DISCUSSION
	Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.They can be used for immediate, early orlate implantation following the extractionor loss of natural teeth. The implants canbe placed with immediate function forsingle-tooth and/or multiple-toothrestorations when good primary stabilityis achieved and with appropriate occlusalloading to restore chewing function	implantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	The Straumann® BLX Implants are suitable fororal and endosteal implantation in the upperand lower jaw and for the functional andesthetic oral rehabilitation of edentulous andpartially dentate patients. Straumann® BLXimplants can be used for immediate or earlyimplantation following extraction or loss ofnatural teeth. Implants can be placed withimmediate function on single-tooth and/ormultiple-tooth applications when good primarystability is achieved and with appropriateocclusal loading, to restore chewing function.The prosthetic restorations used are singlecrowns, bridges and partial or full dentures,which are connected to the implants by thecorresponding elements (abutments).	All indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.
K212533	IFU 702110Straumann® dental implants areindicated for functional and esthetic oralrehabilitation of the upper or lower jaw ofedentulous or partially edentulouspatients.They can be used for immediate, early orlate implantation following the extractionor loss of natural teeth. The implants canbe placed with immediate function forsingle-tooth and/or multiple-toothrestorations when good primary stabilityis achieved and with appropriate occlusalloading to restore chewing function	Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lower jawarches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare indicated for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple-tooth applications whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function. Theprosthetic restorations are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).	Reference Predicate - K212533The Straumann® BLX Implants are suitable fororal and endosteal implantation in the upperand lower jaw and for the functional andesthetic oral rehabilitation of edentulous andpartially dentate patients. Straumann® BLXimplants can be used for immediate or earlyimplantation following extraction or loss ofnatural teeth. Implants can be placed withimmediate function on single-tooth and/ormultiple-tooth applications when good primarystability is achieved and with appropriateocclusal loading, to restore chewing function.The prosthetic restorations used are singlecrowns, bridges and partial or full dentures,which are connected to the implants by thecorresponding elements (abutments).	EquivalentAll indications allow for implantplacement in jaw, providingsupport for single-tooth ormultiple-tooth and allowing forimmediate loading when goodprimary stability is achieved.The prosthetic restorationsinformation was not excludedfrom the Instructions for Use butrelocated to the devicedescription for betterunderstanding.

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Straumann® SLActive® Labeling Changes

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Straumann® SLActive® Labeling Changes

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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.

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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

Regulation Number and Section

§ 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.