UTA AND UHA

K102467 · Uta · NHA · Apr 7, 2011 · Dental

Device Facts

• Record ID: K102467
• Device Name: UTA AND UHA
• Applicant: Uta
• Product Code: NHA · Dental
• Decision Date: Apr 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

UTA and UHA are PEEK screw-retained dental abutments; UTA functions as a temporary abutment for provisional restorations; UHA functions as a healing abutment to protect implant components and support gingival architecture. Both devices are used in clinical dental settings by practitioners; they are placed on endosseous implants during the healing phase. UTA allows attachment of preformed teeth to create emergence profiles. Both devices are restricted to non-occlusal loading and a maximum 180-day intra-oral duration. Clinical benefit includes facilitating proper gingival healing and provisional aesthetics during the implant integration period.

Clinical Evidence

Bench testing only. Fatigue and static testing conducted per modified ISO 14801 (1 million cycles). Results showed strength comparable to predicate temporary abutments for Astra Tech, Biomet, and Zimmer systems.

Technological Characteristics

Materials: PEEK. Form factor: Screw-retained posts (UTA with predefined apex, UHA as healing cap). Compatibility: Multi-brand implant systems (AstraTech, Biohorizons, Biomet, Nobel Biocare, Straumann, Zimmer). Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring provisional dental restorations or healing abutments during the healing phase of endosseous dental implants. UTA is for single-tooth restorations in maxilla or mandible under non-occlusal loading for up to 180 days. UHA is for protecting implant components and supporting gingival architecture under non-occlusal loading for up to 180 days.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• Implant Innovations Preformance Abutment Posts and Temporary Cylinders (K061969)

Submission Summary (Full Text)

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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: [phone]

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.

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.

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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 [phone] or [phone] 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: .

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.

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