3I PATIENT-SPECIFIC OVERDENTURE BAR

K034035 · Implant Innovations, Inc. · NHA · Mar 24, 2004 · Dental

Device Facts

• Record ID: K034035
• Device Name: 3I PATIENT-SPECIFIC OVERDENTURE BAR
• Applicant: Implant Innovations, Inc.
• Product Code: NHA · Dental
• Decision Date: Mar 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The 3i Patient-Specific Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in an edentulous or partially edentulous patient. It is intended for use to support multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be screwed retained.

Device Story

3i Patient-Specific Overdenture Bars function as accessories to endosseous dental implants; provide structural support for multiple tooth prostheses in mandible or maxilla; prostheses are screw-retained to abutment. Device designed to match individual patient anatomy; used by dental professionals in clinical settings. Benefits include stabilization of prosthetic devices for patients with tooth loss. Potential risks include screw fracture, screw loosening, or improper mating leading to inflammation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Patient-specific overdenture bars designed for endosseous dental implant integration. Materials and manufacturing specifications are consistent with traditional dental laboratory-fabricated overdenture bars. No software or electronic components.

Indications for Use

Indicated for edentulous or partially edentulous patients requiring support for multiple tooth prostheses in the mandible or maxilla via endosseous dental implants.

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

• Nobel Biocare, Inc. Procera® Preparable Abutment System (K974150)

Submission Summary (Full Text)

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K034035

Implant Innovations, Inc. 510(k) Premarket Notification - 3i Patient-Specific Dental Abutments

MAR 2 4 2004

Image /page/0/Picture/3 description: The image shows a logo for Implant Innovations, Inc., a Biomet company. The logo features a stylized "3i" with the "i" resembling a dental implant. Below the "3i" are the words "IMPLANT INNOVATIONS, INC." and "A BIOMET COMPANY" in a smaller font.

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## Summary of Safety & Effectiveness

| COMPANY: | Implant Innovations, Inc. 4555 Riverside Drive Palm Beach Gardens, FL 33410 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Jim Banic Regulatory Affairs Specialist Telephone: [phone] Fax: [phone] E-mail: [e-mail] |
| DATE PREPARED: | December 26, 2003 |
| NAME OF THE DEVICE: | 3i Patient-Specific Overdenture Bar |
| CLASSIFICATION: | DZE Class III |
| COMMON NAME: | Overdenture Bar |
| PREDICATE DEVICES: | The 3i Patient-Specific Overdenture Bars are substantially equivalent to overdenture bars, (commonly referred to as Hader, Dolder, and Primary) currently on the market in overall design and intended use. Overdenture bars have been in existence for more than thirty years and have been traditionally fabricated in individual dental laboratories. |
| | Predicate device includes: |
| | K974150 Nobel Biocare, Inc. Procera® Preparable Abutment System |

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Implant Innovations, Inc. 510(k) Premarket Notification - 3i Patient-Specific Dental Abutments

| DEVICE DESCRIPTION: | The 3i Patient-Specific Overdenture Bars are<br>designed to match individual patients. |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR USE: | The 3i Patient-Specific Overdenture Bars are<br>intended for use as an accessory to an endosseous<br>dental implant to support a prosthetic device in a<br>partially or edentulous patient. It is intended for use<br>to support multiple tooth prostheses, in the<br>mandible or maxilla. The prostheses are screw<br>retained to the abutment. |
| SUMMARY OF SAFETY AND<br>EFFECTIVENESS: | Safety and effectiveness problems that have been<br>encountered with overdenture bars used<br>with endosseous implants may include occasional<br>fractures of the screw; screws becoming loose; or<br>improper mating resulting in inflammation. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest movement and progress.

Public Health Service

MAR 2 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jim Banic Regulatory Affairs Specialist Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K034035

Trade/Device Name: 3i Patient-Specific Overdenture Bars Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: December 26, 2003 Received: December 29, 2003

Dear Mr. Banic:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 -- Mr. Banic

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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/cdrh/dsma/dsmamain.html

Sincerely vours,

Chiu Lin, Ph.D.

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

S10(k) Number (if known): K034035

Device Name: 3i Patient-Specific Overdenture Bars

## Indications for Use:

The 3i Patient-Specific Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in an edentulous or partially edentulous patient. It is intended for use to support multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be screwed retained.

Prescription Use > (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Suso Rtmps

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

510(k) Number: K034035

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