Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

Device Description

The subject devices of the Straumann® Dental Implant System includes the following: SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10 & 12 mm SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid® Standard Plus, Ø4.1 RN and Ø4.8 RN, 6. 8. 10. 12 & 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10, & 12 mm Roxolid®, Standard Plus, Ø4.8 WN, 14 mm SLActive® and Roxolid®, Tapered Effect, Ø3.3 RN and Ø4.1 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Tapered Effect, Ø4.8 WN, 10, 12 & 14 mm SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12 & 14 mm

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Straumann® Dental Implant System SLActive and Roxolid Product Families, based on the provided 510(k) summary (K130222):

1. Acceptance Criteria and Reported Device Performance

This 510(k) submission is for a change in Indications for Use, not for a new device requiring performance metrics against specific acceptance criteria for a new product. The device itself (Straumann® Dental Implants) is already cleared and its performance is established through prior submissions.

The "acceptance criterion" in this context is primarily focused on demonstrating substantial equivalence to predicate devices and supporting the modification of the indications for use. This modification specifically aims to remove a limitation on the number of implants required for immediate loading in fully edentulous patients.

Therefore, the "reported device performance" relates to the clinical justification for this change, rather than numerical performance metrics.

Acceptance Criteria (Implicit for Indications for Use Change)	Reported Device Performance (Summary)
Bench and Animal Testing Equivalence: The subject devices remain representative of performance as previously cleared.	The bench and animal performance testing previously submitted in support of the referenced Straumann predicate devices were 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 continues to be representative of the performance of the subject devices. (No new performance data needed here as the device itself hasn't changed).
Clinical Equivalence for Modified Indication: Justify that two immediately loaded dental implants are equivalent to a greater number of implants for treating fully edentulous patients.	A review and summarization of the clinical literature associated with the use of two immediately loaded dental implants in the treatment of fully edentulous patients was performed. The available data indicate that the use of two dental implants to treat fully edentulous patients is common; the evidence supports that performance of two immediately loaded dental implants is equivalent to the use of a greater number of implants for this indication.
Support from Professional Consensus: Align with recognized professional guidelines and consensus statements regarding the proposed change.	Consensus statements from the American Dental Association, the McGill Consensus, and the York Consensus were referenced, indicating that two-implant restoration of fully edentulous mandibles should be the treatment of choice. This literature strongly supports the elimination of the limitation requiring the use of at least four dental implants for the treatment of the fully edentulous patient when the implants are to be immediately loaded.

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

Sample Size for Test Set: Not applicable in the traditional sense of a new clinical trial with a "test set" for a device. The study described is a clinical literature review. Therefore, the "sample size" is the cumulative patient data across the various clinical studies analyzed within the literature review. The exact number of patients or studies included in the review is not specified in this 510(k) summary.
Data Provenance: The data provenance is from clinical literature, which typically includes studies conducted in various countries; specific countries are not mentioned. The studies would be retrospective and prospective in their original design, but the analysis presented here is a retrospective review of existing publications.

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

Number of Experts: This aspect is not directly applicable to this type of submission. The "ground truth" for the modified indication is established through the body of scientific evidence in peer-reviewed clinical literature and professional consensus statements.
Qualifications of Experts: The "experts" whose opinions form the basis of the mentioned consensus statements (American Dental Association, McGill Consensus, York Consensus) would be recognized leaders and specialists in dentistry and implantology. Their specific qualifications (e.g., years of experience as a radiologist) are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no "test set" in the sense of a set of cases requiring independent expert review and adjudication for a device's performance. The clinical literature review relies on the outcomes and conclusions reported in peer-reviewed publications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used to evaluate diagnostic imaging devices or AI algorithms where multiple human readers interpret cases with and without AI assistance. This 510(k) is about an implant system and its indications for use, not an interpretation aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No, a standalone study was not done. This device is a dental implant, not an AI algorithm. Therefore, "algorithm only" performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for justifying the change in indications for use is based on:

Clinical Literature Evidence: Published clinical studies and data demonstrating the efficacy and safety of two immediately loaded dental implants for fully edentulous patients.
Expert Consensus Statements: Formal recommendations and conclusions from recognized professional bodies (American Dental Association, McGill Consensus, York Consensus) in the field of dental implantology.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This submission concerns a physical medical device (dental implants) and a change to its indications for use, not an AI algorithm that requires a training set. The "training" for the device's original clearance and subsequent sustained use comes from years of clinical practice and research.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" in the context of this device and submission type. For the original clearance of the implants, ground truth would have been established through pre-clinical testing (bench, animal) and clinical trials (human studies) demonstrating safety and effectiveness, based on recognized clinical outcomes and expert assessment.

Summary

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K1302222

Traditional 510(k) Submission.

Change in Straumann Dental Implant Indications for Use

APR 2 9 2013

5. 510(k) Summary

Submitter's Contact Information 5.1

Straumann USA, LLC (on behalf of Institut Straumann AG)

60 Minuteman Road

Andover, MA 01810

Contact Person:	Jennifer M. Jackson, MS or	Christopher Klaczyk
Phone Number:	1-978-747-2509	1-978-747-2575
Fax Number:	1-978-747-0023	1-978-747-0023

Date of Submission: 28-Jan-2013

5.1 Name of the Device

Trade Name:	Straumann® Dental Implant System
	SLActive and Roxolid Product Families

Common Name: Dental Implants

Classification Name: Implant, Endosseous, Root-form

Regulation Number: §872.3640

5.2 Predicate Device(s)

K033922, Modification to ITI Dental Implant System

K033984, ITI Dental Implant System

K053088, SLActive Implants

K062129, P.004 Implants

K081419, Modified Dental Implant

K083550, Modified Dental Implant

K111357, Narrow Neck CrossFit (NNC) Ø3.3 mm Dental Implant System

K121131, Straumann Bone Level Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants

K122855, Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Roxolid Dental Implants

K123784, Straumann Dental Implant System - SLA, SLActive and Roxolid Product Families

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Traditional 510(k) Submission

Change in Straumann Dental Implant Indications for Use

Device Description 5.3

5.4 Indications For Use / Intended Use

5.5 Technological Characteristics

The subject devices are identical to the corresponding Straumann predicate devices as far as design, materials, surface treatments, fundamental operating principles, and sterilization processes and procedures. The change proposed in this premarket notification modifies the Indications for Use for the SLActive® and Roxolid® dental implants.

There are no changes to or new surgical instruments or secondary components being introduced as a result of the proposed change.

5.6 Performance Testing

The bench and animal performance testing previously submitted in support of the referenced Straumann predicate devices were 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 continues to be representative of the performance of the subject devices.

A review and summarization of the clinical literature associated with the use of two immediately loaded dental implants in the treatment of fully edentulous patients. The available data indicate that the use of two dental implants to treat fully edentulous patients is common; the evidence supports that performance of two immediately loaded dental implants is equivalent to the use of a greater number of implants for this indication. We also provide

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Change in Straumann Dental Implant Indications for Use

consensus statements from the American Dental Association, the McGill Consensus and the York Consensus indicating that two implant restoration of fully edentulous mandibles should be the treatment of choice. This literature strongly supports the elimination of the limitation requiring the use of at least four dental implants for the treatment of the fully edentulous patient when the implants are to be immediately loaded.

5.7 Conclusion

The documentation submitted in this premarket notification supports the proposed modification to the Indications for Use of the SLActive® and Roxolid® dental implants. The subject devices are substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66 Silver Spring, MD 20993-0002

April 29, 2013

Ms. Jennifer M. Jackson, MS Senior Regulatory Affairs Project Manager Straumann USA, Limited Liability Company 60 Minuteman Road ANDOVER MA 01810

Re: K130222

Trade/Device Name: Straumann® Dental Implant System SLActive and Roxolid Product Families Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 28, 2013 Received: January 29, 2013

Dear Ms. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21-GFR-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/Medica!Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer -S for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known); K130222

Device Name:

Straumann® Dental Impiant System SLActive and Roxolid Product Families

Indications for Use:

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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	Digitally signed by Mary S. Runner - S
	ON: c=US, o=U.S. Government,
	ou=HHS, ou=FDA, ou=People,
	cn=Mary S. Runner - S,
	0.9.2342.19200300.100.1.1=13000879
	Date: 2013.04.29 09:55:02 -04'00'

Susan Runner, DDS, DA

Division Sign-Off) (Division Sign-Sill)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 1 of 1

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.