K Number

Device Name

Manufacturer

UTA

Date Cleared

2011-04-07

(220 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K061969

Predicate For

N/A

Intended Use

The UTA is intended for use to fabricate and support provisional restorations that aid in creating proper emergence profiles and support gingival architecture throughout the healing phase. It is for use in single tooth restorations in the maxilla or mandible, with non occlussal loading. The UTA can be used for up to one hundred eighty days (180) intra orally.

The UTA is compatible with AstraTech 3.5/4.0 & 4.5/5.0, Biohorizons 3.2/4.5/6, Biomet 3.4, 4.1 & 5, Nobel Biocare Branemark, Nobel Biocare Active Internal RP(4.1/5)&NP(3.5), Nobel Biocare Select NP(3.5)& RP/WP(4.3/5), Nobel Biocare Replace 4.3, Straumann Bone Level NC &RC (4), and Zimmer 3.75, 4.5 &6.

UHA are placed on top of implants to protect the inner components of the implants throughout the healing phase. UHA creates support for gingival architecture and can be used with cement-retained temporary prostheses. It should be placed in non occlusal loading. It can be used for up to 180 days.

The UHA is compatible with AstraTech 3.5/4.0 & 4.5/5.0, Biohorizons 3.2/4.5/6, Biomet 3.4, 4.1 & 5, Nobel Biocare Branemark, Nobel Biocare Active Internal RP(4.1/5)&NP(3.5), Nobel Biocare Select NP(3.5)& RP/WP(4.3/5), Nobel Biocare Replace 4.3, Straumann Bone Level NC &RC (4), and Zimmer 3.75, 4.5 &6.

Device Description

UHA is a healing abutment which is a PEEK screw-retained post. UTA is a screwretained temporary abutment which is a PEEK post with a predefined apex so a preformed tooth can be attached. Screws are available for Astra Tech 3.5/4.0 &4.5/5.0, Biohorizon 3.2/4.5/6.0, Biomet 3.4/4.0/5.0, Nobel Biocare Branemark, Nobel Biocare Active Internal 4.1/5.0(RP/WP) & 3.5(NP), Nobel Biocare Select 4.3/5.0(RP/WP) & 3.5(NP), Nobel Biocare Replace 4.3, Straumann Bone Level 4.0 NC &RC, Zimmer 3.75/4.5/6.0.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Static Strength	Similar strength to predicate temporary abutments (Astra Tech, Biomet, Zimmer).
Fatigue Life (1 Million Cycles, adjusted for <180 days use)	Results similar to fatigue testing of predicate PEEK temporary abutments (AstraTech 3.5/4, Biomet 3.4).
Material Composition	Similar material (PEEK) to predicate abutments.
Intended Use	Subset of predicate indications (single tooth restoration, non-occlusal loading).
Intraoral Use Duration	Up to 180 days, same as predicate device.

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

The document does not explicitly state the exact sample sizes used for the test sets in the static and fatigue testing. It generally refers to testing "with Astra Tech in both screw sizes," "Biomet 3i in both sizes," "Nobel Select 3.5," and "Nobel Biocare Branemark." This suggests that multiple abutments for various implant systems were tested, but specific numbers are not provided.

The data provenance is not explicitly stated, but based on the context of a 510(k) submission to the FDA, it is highly likely that these were prospective laboratory studies conducted specifically for this submission. The country of origin is not mentioned, but the submitting company is based in Dayton, Ohio, USA, suggesting the testing was likely conducted in the USA or by labs commissioned by the US-based company.

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

This information is not applicable as the evaluation involved physical testing (static and fatigue) of medical devices, not an assessment of data where expert ground truth would typically be established (e.g., image interpretation). The "ground truth" in this context is determined by the physical properties and performance of the devices under specified test conditions.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods are typically relevant for human-involved assessments (e.g., expert consensus on medical images).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as the evaluation involved physical testing of medical devices, not human interpretation of medical cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical medical implant (temporary abutment), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.

7. Type of Ground Truth Used

The "ground truth" was established through physical testing and engineering standards. Specifically:

Static Strength: The ultimate force or load the abutment could withstand before failure.
Fatigue Life: The number of cycles the abutment could endure under a specified load before failure.
Material Composition: Verified through material analysis to confirm PEEK.

The comparison was made against the performance of legally marketed predicate devices under the same test conditions.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical implant, not an AI model or software that requires a training set.

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

This information is not applicable for the reasons stated above.

Summary

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102467

APR - 7 2011

510(k) Summary of Safety and Effectiveness

August 23, 2010

Submitted by: Joe Wiener Managing Partner

Address: UTA

3318 Successful Way Dayton, Ohio 45414

Telephone: 937 608 0557

Classification Name: Endosseous Dental Implant Abutment 21 CFR 872.3630

Trade Name: UTA and UHA

Legally Marketed Device: Implant Innovations Preformance Abutment Posts and Temporary Cylinders K061969 (now under Biomet 3i)

Device Description: UHA is a healing abutment which is a PEEK screw-retained post. UTA is a screwretained temporary abutment which is a PEEK post with a predefined apex so a preformed tooth can be attached. Screws are available for Astra Tech 3.5/4.0 &4.5/5.0, Biohorizon 3.2/4.5/6.0, Biomet 3.4/4.0/5.0, Nobel Biocare Branemark, Nobel Biocare Active Internal 4.1/5.0(RP/WP) & 3.5(NP), Nobel Biocare Select 4.3/5.0(RP/WP) & 3.5(NP), Nobel Biocare Replace 4.3, Straumann Bone Level 4.0 NC &RC, Zimmer 3.75/4.5/6.0.

Indications for Use: The UTA is intended for use to fabricate and support provisional restorations that aid in creating proper emergence profiles and support gingival architecture throughout the healing phase. It is for use in single tooth restorations in the maxilla or mandible, with non occlussal loading. The UTA can be used for up to one hundred eighty days (180) intra orally.

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Testing:

Fatigue and static testing comparing the UTA to predicate temporary abutments was conducted. The ISO 14801 test method was modified for 1 million cycles (adjusted for the less than 180 day use of temporaries) and the setup did not include the 3mm holding line because the temporary abutments are too short to allow this type of fixation.

Substantial Equivalence:

The UTA and UHA are of similar material to the predicate abutments, PEEK. The indications for UTA and UHA are a subset of the predicate indications (e.g. UTA is only for single tooth restoration and neither UTA nor UHA would normally be used in completely edentulous cases). UTA and UHA are for use for the same time period, up to 180 days, as the predicate device from Biomet 3i.

Static testing showed similar strength for the UTA and the implant company s temporary abutments for Astra Tech, Biomet, and Zimmer. Fatigue testing was completed for UTA used with Astra Tech in both screw sizes, with Biomet 31 in both sizes, Nobel Select 3.5 and Nobel Biocare Branemark. The results were similar to fatigue testing of AstraTech 3.5/4 with its PEEK temporary abutment and Biomet 3.4 with its PEEK temporary abutment.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The seal is black and white and appears to be a high-contrast image.

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

UTA C/O Ms. Angela Blackwell Senior Consultant Biologics Consulting Group 3318 Successful Way Dayton, Ohio 45414

APR - 7 200

Re: K102467

Trade/Device Name: UTA and UHA Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 30, 2011 Received: March 31, 2011

Dear Ms. Blackwell:

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. Blackwell

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 on our news of the Act or any Federal statutes and regulations administered by other l'ederal 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 CDRF1'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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

h far

Anthony 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): K102467

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use: .

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Riane

(Division Sign-On)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices,
510(k) Number: 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.)