Straumann Temporary Abutments VITA CAD-Temp are indicated for use with Straumann Bone Level and Tissue Level implants for temporary crown and bridge restorations, and to maintain, stabilize and shape the soft tissue during the healing phase for up to six months, and should be placed out of occlusion.

Device Description

Straumann Temporary Abutments VITA CAD-Temp are temporary abutments intended for placement on Straumann Bone Level and Straumann Tissue Level implants of corresponding diameter. The temporary abutments are made of polymethyl methacrylate (PMMA), with a Titanium Alloy inlay.

AI/ML Overview

The manufacturer performed fatigue testing and sterilization validation to ensure that the device functions as intended and meets predetermined acceptance criteria.

1. A table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
Fatigue Testing	Based on the performance of predicate devices as outlined in the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."	The proposed devices met or surpassed the acceptance criteria.
Sterilization Validation	In accordance with ISO 17665-1 and ISO 17665-2 for moist heat sterilization (overkill method, partial cycle).	Requirements were met, and there were no deviations to the applicable standards.

2. Sample size(s) used for the test set and the data provenance:

Fatigue Testing: The specific sample size for fatigue testing is not explicitly stated in the provided text.
Sterilization Validation: The specific sample size for sterilization validation is not explicitly stated in the provided text.
Data Provenance: Not specified, but generally, such tests are conducted in a controlled laboratory environment by the manufacturer or a third-party testing facility. The document does not indicate country of origin for data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to the described testing. The described tests (fatigue and sterilization) are bench tests and do not involve expert interpretation or ground truth establishment in the clinical sense. The ground truth for fatigue testing is the mechanical integrity of the device under stress, determined by engineering principles and comparison to predicate devices. For sterilization, it's the successful elimination of microorganisms.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable to the described bench tests. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document describes the premarket notification for a dental implant abutment, which is a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This document describes the premarket notification for a physical medical device. There is no algorithm involved in the function of the Straumann Temporary Abutments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Fatigue Testing: The "ground truth" for fatigue testing is the mechanical performance and integrity of the device under specified loading conditions, with acceptance criteria based on the demonstrated performance of legally marketed predicate devices. This is an engineering/bench test "ground truth."
Sterilization Validation: The "ground truth" for sterilization validation is the sterility assurance level achieved, demonstrating the elimination of microorganisms according to established international standards (ISO 17665-1 and ISO 17665-2). This is a microbiological/bench test "ground truth."

8. The sample size for the training set:

Not applicable. This device is a physical medical device and does not involve machine learning or a "training set."

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for this device, a ground truth for it was not established.

Summary

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K122192

Straumann Temporary Abutments, PMMA Traditional 510(k) Section 5: 510(k) Summary

straumann

NOV 2 2012

1. Applicant's Name and Address

Straumann USA, LLC (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 Requlatory Project Manager

Date of Submission: 2. July 23, 2012

3. Name of the Device

Trade Name:	Straumann Temporary Abutments VITA CAD-Temp
Common Name:	Temporary Abutments
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	§872.3630

1. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) K072679, Straumann NC Temporary Abutment K070478, Straumann RC Temporary Abutment
  K051717, Straumann RN synOcta Temporary Abutment K111357, Straumann NNC Post for Temporary Restoration

ર. Description of the Device

6. Intended Use of the Device

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122192

7. Technological Characteristics

The proposed devices are substantially equivalent to the currently marketed devices. They share the same indication for use, prosthetic platforms, implant/abutment connections, fundamental operating principles, and contact duration of up to six months. Changes to the proposed devices are listed below followed by a comparison table, Table 1, listing each proposed and predicate device and the respective changes:

· Material change from PEEK to PMMA, and from Titanium Alloy to PMMA,
· Design changes of the coronal aspects of the abutments including length and diameter.

Change	Proposed Device	Predicate Device
	NC Temporary Abutment, PMMA	NC Temporary Abutment, PEEK
Material	PMMA, polymethyl methacrylate	PEEK, polyetheretherketone
Length	14.65mm	14.75mm
Change	Proposed Device	Predicate Device
	RC Temporary Abutment, PMMA	RC Temporary Abutment, PEEK
Material	PMMA, polymethyl methacrylate	PEEK, polyetheretherketone
Length	16.30mm	16.40mm
Change	Proposed Device	Predicate Device
	RN Temporary Abutment, PMMA	RN synOcta Temporary Abutment, PEEK
Material	PMMA, polymethyl methacrylate	PEEK, polyetheretherketone
Change :	Proposed Device	Predicate Device
	WN Temporary Abutment, PMMA	RN synOcta Temporary Abutment, PEEK
Material	PMMA, polymethyl methacrylate	PEEK, polyetheretherketone
Diameter	10.10mm	7.0mm
Implant	Ø 4.8mm Wide Neck Tissue	Ø3.3, 4.1 and 4.8mm Regular Neck
Compatibility	Level Implant	Tissue Level Implants
ProstheticPlatform	Ø 6.5mm	Ø 4.5mm
Change	Proposed Device	Predicate Device
	NNC Temporary Abutment, PMMA	NNC Post for Temporary Restoration, -
Material	PMMA, polymethyl methacrylateTitanium Alloy Inlay, Ti6Al7Nb	Titanium Alloy, Ti6Al7Nb
Diameter	5.0mm	3.70 mm

Table 1: Comparison Table

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:

Revised 510(k) Summary Straumann, USA, LLC

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1. Performance Testing
- FDA guidance document "Class II Special Controls Guidance ﻨﺖ. Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
  - 1. Fatigue testing was performed in accordance to the test set-up of the guidance document for systems that include polymeric components. Compressive and shear (lateral) forces were tested; successful testing was measured by the predetermined acceptance criteria which was based on the predicate devices. Angled abutment testing was not performed as no angled devices were proposed. The proposed devices met or surpassed the acceptance criteria.
1. Sterilization Validation
- i. Sterilization validation was carried out in accordance with ISO 17665-1 (overkill method, partial cycle): Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, and ISO 17665-2: First edition 2009-01-15 Technical Specification Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.
  - 1. Requirements were met; there were no deviations to the applicable standards.

9. Conclusion

The results from the testing conducted demonstrated that the Straumann Temporary Abutments VITA CAD-Temp function as intended and met the predetermined acceptance criteria.

The results of the performance bench testing and risk analysis indicate that the Straumann Temporary Abutments VITA CAD-Temp are substantially equivalent to the named predicate devices.

Revised 510(k) Summary Straumann, USA, LLC

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another person, represented by three curved lines.

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

NOV 2 2012

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

Re: K122192

Trade/Device Name: Straumann Temporary Abutments VITA CAD-Temp Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 8, 2012 Received: October 9, 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.

ph foc

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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Indications for Use

510(k) Number (if known):

Device Name: Straumann Temporary Abutments VITA CAD-Temp

Indications for Use:

X Prescription Use (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 CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

510(k) Number: K122190

Response Letter: K122192 Straumann Temporary Abutments, PMMA Straumann, USA, LLC

October 5, 2012 Page 7 of 44

Page 1 of 1

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)