MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS

K052648 · Implant Innovations, Inc. · NHA · Oct 20, 2005 · Dental

Device Facts

• Record ID: K052648
• Device Name: MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS
• Applicant: Implant Innovations, Inc.
• Product Code: NHA · Dental
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 3i Patient-Specific Dental Abutments and Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Device Story

Patient-specific dental abutments and overdenture bars; accessory to endosseous dental implants. Designed to match individual patient anatomy based on doctor requirements. Supports single or multiple tooth prostheses; screw or cement retained. Used in clinical dental settings by practitioners. Provides structural support for prosthetic teeth; restores function and aesthetics for patients with missing teeth.

Clinical Evidence

bench testing only

Technological Characteristics

Patient-specific dental abutments and overdenture bars. Designed for individual patient anatomy. Compatible with endosseous dental implants. No specific materials or software algorithms described.

Indications for Use

Indicated for partially or edentulous patients requiring support for single or multiple tooth prostheses in the mandible or maxilla, used as an accessory to 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

• 3i Patient-Specific Dental Abutments (K032263)

Submission Summary (Full Text)

{0}------------------------------------------------

# OCT 2 0 2005

K052648

#### Summary of Safety and Effectiveness

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 | Jim Banic<br>Regulatory Affairs Specialist<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 | September 20, 2005 | |
| Device Name | Patient-Specific Dental Abutments | |
| Classification Name | Dental Abutments | |
| Device<br>Classification | Class II<br>Dental Devices Panel<br>21 CFR § 872.3630 | |
| Predicate<br>Devices | 3i Patient-Specific Dental Abutments<br>K032263 | |
| 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 3i Patient-Specific Dental Abutments are designed to<br>match an individual patient. Since each 3i Patient-Specific<br>Dental Abutment is manufactured to match a particular<br>patient according to the doctor's requirements, a specific | |

{1}------------------------------------------------

device description is not possible.

K65 2648

However, the 3i Patient-Specific Dental Abutments are designed in keeping with the general descriptions presented in Section G, unless otherwise specifically requested by the doctor.

- The 3i Patient-Specific Dental Abutments and Overdenture Indications for Use Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.
- The 3i Patient-Specific Dental Abutments contain features Technological and functions which are similar to the currently available 3i Characteristics Patient-Specific Dental Abutments [K032263].
- Conclusion The 3i Patient-Specific Dental Abutments are substantially equivalent to the legally marketed 31 Patient-Specific Dental Abutments.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper half of the circle.

### OCT 2 0 2005

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: K052648

Trade/Device Name: Modification to 3i Patient-Specific Dental Abutments and Overdenture Bars Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: NHA Dated: September 20, 2005 Received: September 26, 2005

Dear Mr. Banic:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed yoursed your with 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 incersate commerce proct to traylave been reclassified in accordance with the provisions of Amendinents, or to act 1000 and Cosmetic Act (Act) that do not require approval of a premarket the Federal Food, Drag, and Orbu may, therefore, market the device, subject to the general approvin uppineation (The Act. The general controls provisions of the Act include controls providents of a 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 If your device to such additional controls. Existing major regulations affecting (1 Mr), it may of buryev to fines of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

#### Page 2 - Mr. Banic

Please be advised that FDA's issuance of a substantial equivalence determination does not r least oc auvrsed that 1 Dr. I termination that your device complies with other requirements mean that ITA has made a determinaregulations administered by other Federal agencies. of the Act of ally i edelar statues and rightenents, including, but not limited to: registration r ou must comply with an an e labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Part 067), acciity systems (QS) regulation (21 CFR Part 820); and if requirements as sectionic product radiation control provisions (Sections 531-542 of the Act); applicable, the clections proute will allow you to begin marketing your device as described 21 CFK 1000-1030. This lease will affication. The FDA finding of substantial equivalence In your Section 510(x) promaticate 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), If you desire specific advice for your are 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Drisber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

fer

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

{4}------------------------------------------------

Page 1 __ of 1

## Indications for Use

| 510(k) Number (if known): | K052648 |
|---------------------------|-------------------------------|
| Device Name: | 3i Patient Specific Abutments |

Indications for Use:

The 3i Patient-Specific Dental Abutments and Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend for use to support single and multiple tooth prostheses, in The prostheses can be screw or cement retained to the the mandible or maxilla. abutment.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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)

Susan Quorn

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

510(k) Number: K050645

Page 1 of