CONICAL ANGLED ABUTMENT

K063403 · Implant Innovations, Inc. · NHA · Mar 20, 2007 · Dental

Device Facts

• Record ID: K063403
• Device Name: CONICAL ANGLED ABUTMENT
• Applicant: Implant Innovations, Inc.
• Product Code: NHA · Dental
• Decision Date: Mar 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

3i's Conical Angled Abutments are indicated for use in single and multiple unit cases and as custom copings where tissue depth, as measured from the crest of the tissue to the shelf of the implant; angulation of the implant in relation to other implants or adjacent dentition; and, interarch distance measured form the shelf of the implant to the opposing dentition, provide for improved emergence profiles and contours for esthetic restorations.

Device Story

Conical Angled Abutments interface with 3i internal and external connected dental implants; used to support single/multiple unit restorations or custom copings. Device features 17° and 25° angles; 4.1mm and 5.0mm diameter seating surfaces; 2.0mm and 4.0mm transmucosal tissue heights. Operated by dental professionals in clinical settings to address anatomical challenges like implant angulation or limited interarch distance. Output provides improved emergence profiles and esthetic contours for dental restorations, facilitating prosthetic placement.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manufactured from Titanium Alloy. Designed for 3i internal and external connected implants. Available in 17° and 25° angles, 4.1mm/5.0mm diameters, and 2.0mm/4.0mm tissue heights. Mechanical interface.

Indications for Use

Indicated for patients requiring single or multiple unit dental restorations or custom copings where specific tissue depth, implant angulation, or interarch distance necessitates angled abutments to improve emergence profiles and esthetic contours.

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

• Conical Abutment (K933462)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness

## MAR 2 0 2007

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

| Submitter | Implant Innovations, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| Contact | Tamara Nelson<br>Regulatory Affairs Supervisor<br>Implant Innovations, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410<br>Tel. [phone]<br>Fax. [phone]<br>Email: [e-mail] |
| Date Prepared | 03 November 2006 |
| Device Name | Conical Angled Abutments |
| Classification Name | Endosseous Dental Implant Abutment |
| Device<br>Classification | Class II<br>Dental Devices Panel<br>21 CFR § 872.3630 |
| Predicate<br>Devices | Conical Abutment -> K933462 |
| Performance | Performance standards have not been established by the<br>FDA under Section 514 of the Federal Food, Drug and<br>Cosmetic Act. |
| Device Description | The Conical Angled Abutments are designed to interface<br>with 3i's internal and external connected implants. They<br>will be available in 17° and 25° angles. The seating surface<br>will be 4.1mm and 5.0mm diameters and the transmucosal<br>tissue heights will be 2.0mm and 4.0mm. They will be<br>manufactured out of Titanium Alloy. |
| Indications for Use | 3i's Conical Angled Abutments are indicated for use in<br>single and multiple unit cases and as custom copings where<br>tissue depth, as measured from the crest of the tissue to the |

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shelf of the implant; angulation of the implant in relation to other implants or adjacent dentition; and, interarch distance measured form the shelf of the implant to the opposing dentition, provide for improved emergence profiles and contours for esthetic restorations.

The Conical Angled Abutments contain features and functions similar to the currently available Conical Abutments.

The Conical Angled Abutments in this submission are substantially equivalent to the legally marketed Conical Abutments.

Technological Characteristics

Conclusion

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tamara Nelson Regulatory Affairs Supervisor Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

MAR 2 0 2007

Re: K063403

Trade/Device Name: Conical Angled Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 9, 2007 Received: March 12, 2007

Dear Ms. Nelson:

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 – Ms. Nelson

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 vour 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/industry/support/index.html.

Sincerely yours.

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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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Conical Angled Abutments

Indications for Use:

31's Conical Angled Abutments are indicated for use in single and multiple unit cases and as custom copings where tissue depth, as measured from the crest of the tissue to the shelf of the implant; angulation of the implant in relation to other implants or adjacent dentition; and, interarch distance measured form the shelf of the implant to the opposing dentition, provide for improved emergence profiles and contours for esthetic restorations. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Kusno

KC62403

Prescription Use: (Per 21 CFR 801.109) OR

Over the Counter Use: