Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

Device Description

The proposed Straumann Bone Level (BL) Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid (TiZr) Dental Implants are an extension to the current Bone Level Roxolid implant portfolio. Straumann currently has Bone Level Ø3.3 mm Narrow Connection (NC) Roxolid dental implants with a prosthetic platform of Ø3.3 mm.

The proposed devices are Bone Level (BL) Roxolid dental implants in diameters of 4.1 mm and 4.8 mm. The implants will be available in 4 lengths; 8.0 mm, 10.0 mm, 12.0 mm and 14.0 mm.

The body of the proposed implants has a threaded implant body design made of Straumann's Titanium Zirconium (TiZr) Alloy material with Straumann's SLActive surface treatment currently cleared under K083550. The proposed changes are design changes only. There are no changes to the material, surface treatment, indications for use, fundamental operating principles, or sterilization processes or procedures as a result of the proposed design changes. No new surgical instruments are being introduced as placement of the proposed implants will follow the established surgical protocols of the currently cleared Straumann Dental Implant Systems.

AI/ML Overview

The Straumann Bone Level Ø4.1mm and Ø4.8mm RC Roxolid Implants are dental implants used for oral endosteal implantation. The performance testing was conducted to ensure the device's intended function and that its design input matches the design output.

Here's an analysis of the acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Fatigue Testing: In accordance with ISO 14801:2007(E), Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.	The manufacturer states: "The results from the testing conducted demonstrated that the Straumann Bone Level (BL) Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants function as intended and met the pre-determined acceptance criteria." While specific numerical performance values are not given, the claim is that the device met the criteria of this standard, implying sufficient fatigue resistance.

Acceptance Criteria

Reported Device Performance

Fatigue Testing: In accordance with ISO 14801:2007(E), Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.

The manufacturer states: "The results from the testing conducted demonstrated that the Straumann Bone Level (BL) Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants function as intended and met the pre-determined acceptance criteria." While specific numerical performance values are not given, the claim is that the device met the criteria of this standard, implying sufficient fatigue resistance.

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

The document does not explicitly state the sample size used for the fatigue testing. The testing type, "Performance Testing," under "Fatique Testing in accordance to ISO 14801:2007(E)," typically involves a controlled laboratory environment using physical samples of the device.

Sample Size: Not explicitly stated.
Data Provenance: The testing was conducted by Straumann itself as part of their verification and validation process. This is laboratory bench testing, not clinical data from patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable in the human data sense.

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

This information is not applicable. The "ground truth" for this type of device (dental implant mechanical performance) is established by adherence to a recognized international standard (ISO 14801:2007) and engineering principles, rather than expert clinical consensus. The standard itself defines the methodology and acceptance criteria.

4. Adjudication Method for the Test Set:

This information is not applicable as the "test set" refers to physical devices undergoing mechanical testing, not clinical cases requiring expert adjudication. The compliance with the ISO standard serves as the "adjudication."

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical performance and substantial equivalence of new implant diameters to existing cleared devices, primarily through bench testing. It does not involve human readers evaluating clinical cases.

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

This is not applicable. The device is a physical dental implant, not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used:

The ground truth used for this performance testing is compliance with international standards (ISO 14801:2007(E)) for dynamic fatigue testing of endosseous dental implants. This standard sets the scientific and engineering benchmarks for evaluating a device's mechanical integrity under simulated physiological conditions.

8. The Sample Size for the Training Set:

This is not applicable. As the device is a physical dental implant and not an AI or software device, there is no "training set." The development would involve engineering design, finite element analysis (FEA), and physical prototyping/testing, but not a data training set in the machine learning sense.

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

This is not applicable as there is no "training set" for this type of device. The design and manufacturing processes are validated through engineering principles and compliance with quality management systems.

Summary

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K121131

Straumann Bone Level Ø4.1mm and Ø4.8mm RC Roxolid Implants Traditional 510(k) Section 5: 510(k) Summary

JUN - 6 2012

1. Applicant's Name and Address

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Project Manager

1. Date of Submission: April 12, 2012

3. Name of the Device

Trade Name:	Straumann Bone Level (BL) Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants
Common Name:	BL Ø4.1 mm and Ø4.8 mm RC RXD Dental Implants
Classification Name:	Implant, Endosseous, Root-form
Regulation Number:	§872.3640

Legally Marketed Device to which Equivalence is Claimed (Predicate 1. Device)
K083550. Straumann Dental Implant System K062129, Straumann P.004 Dental Implants

5. Description of the Device

The proposed devices are Bone Level (BL) Roxolid dental implants in diameters of 4.1 mm and 4.8 mm. The implants will be available in 4 lengths; 8.0 mm, 10.0 mm, 12.0 mm and 14.0 mm.

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Straumann Bone Level Ø4.1mm and Ø4.8mm RC Roxolid Implants Traditional 510(k) Section 5: 510(k) Summary

6. Intended Use of the Device

Technological Characteristics 7.

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Straumann Bone Level Ø4.1mm and Ø4.8mm RC Roxolid Implants Traditional 510(k) Section 5: 510(k) Summary

8. Performance Testing

Verification and validation testing were performed to ensure that the devices subject to this 510(k) Premarket Notification function as intended and that design input matches design output. Testing included:

1. Performance Testing
- a. Fatique Testing in accordance to ISO 14801:2007(E), Dentistry-Implants-Dynamic fatigue test for endosseous dental implants.

9. Conclusion

The results from the testing conducted demonstrated that the Straumann Bone Level (BL) Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants function as intended and met the pre-determined acceptance criteria.

The Straumann Dental Implant System is a validated system. The results of the performance bench testing and risk analysis indicate that the Straumann Bone Level (BL) Ø4.1 mm and Ø4.8 Regular Connection (RC) Roxolid Dental Implants are substantially equivalent to the named predicate devices.

RE: 510(k) Straumann BL Ø4.1 and Ø4.8 RC Roxolid Implants

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Elaine Alan Regulatory Project Manager Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

JUN - 6 2012

Re: K121131

Trade/Device Name: Straumann Bone Level Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants

Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: 11 Product Code: DZE Dated: April 12, 2012 Received: April 13, 2012

Dear Ms. Alan:

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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Page 2 - Ms. Alan

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. .

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

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

Enclosure

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K121131

Indications for Use

510(k) Number (if known):

Device Name: Straumann Bone Level Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of BCRH, Office of Device Evaluation (ODE)
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(Division Sign-Jir)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K12115

RE: 510(k) Straumann BL Ø4.1 and Ø4.8 RC Roxolid Implants

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.