PRIMACONNEX CERAMIC ABUTMENTS

K062876 · Lifecore Biomedical, Inc. · NHA · Nov 1, 2006 · Dental

Device Facts

• Record ID: K062876
• Device Name: PRIMACONNEX CERAMIC ABUTMENTS
• Applicant: Lifecore Biomedical, Inc.
• Product Code: NHA · Dental
• Decision Date: Nov 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

Device Story

PrimaConnex Ceramic Abutments are dental components used in conjunction with the PrimaConnex Internal Connection Implant System. They serve as the interface between an endosseous dental implant and a cement-retained dental restoration. The device is used in clinical dental settings by licensed practitioners to support single or multiple-unit restorations in partially or fully edentulous patients. The abutment provides the structural foundation for the final prosthetic crown or bridge. By utilizing ceramic materials, the device offers an aesthetic alternative to traditional metal abutments while maintaining the same fundamental scientific technology and design as the predicate systems.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and technological comparisons to predicate devices.

Technological Characteristics

Ceramic abutment for endosseous dental implants. Utilizes biocompatible ceramic material identical to predicate devices. Designed for internal connection to the PrimaConnex Implant System. Sterilized using established processes consistent with predicate devices.

Indications for Use

Indicated for use with PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae to support single or multiple-unit cement-retained dental restorations.

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

• Esthetic Contour Straight Abutments for the PrimaConnex Internal Connection Implant System (K051614)
• PrimaConnex Ceramic Copings (K060530)
• Astra Tech Implants - Dental System Ceramic Abutment (K023631)

Submission Summary (Full Text)

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# K062876

### Lifecore Biomedical, Inc. Special 510(k) Premarket Notification PrimaConnex® Ceramic Abutments

NOV - 1 2006

#### 510(K) SUMMARY [As required by 21 CFR 807.92(c)]

### 1. Submitter's Name and Contact Person

| Lifecore Biomedical, Inc. | Brian Smekal |
|---------------------------|-------------------------------------|
| 3515 Lyman Blvd | Regulatory Affairs Specialist |
| Chaska, MN 55318 | Ph: 952-368-6306; Fax: [phone] |

#### 2. General Information

| Trade Name | PrimaConnex® Ceramic Abutments |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Ceramic Abutments |
| Classification Name | Endosseous Implant Abutment |
| Identification of Predicate Devices | Esthetic Contour Straight Abutments for<br>the PrimaConnex Internal Connection<br>Implant System, Lifecore Biomedical<br>(K051614)<br><br>PrimaConnex Ceramic Copings, Lifecore<br>Biomedical (K060530)<br><br>Astra Tech Implants - Dental System<br>Ceramic Abutment, Astra Tech, Inc.<br>(K023631) |

#### 3. Device Description

PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

#### 4. Intended Use

PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous

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### Lifecore Biomedical, Inc. Special 510(k) Premarket Notification PrimaConnex® Ceramic Abutments

mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

#### 5. Substantial Equivalence Comparison

Summary of how the PrimaConnex Ceramic Abutment is substantially equivalent to the PrimaConnex Esthetic Contour Abutment (K051614):

- . Have the same intended use,
- Incorporate the identical design, .
- . Have the same shelf life, and
- Are packaged and sterilized using the same materials and processes. .

Summary of how the PrimaConnex Ceramic Abutment is substantially equivalent to the PrimaConnex Ceramic Copings (K060530):

- Incorporate the identical biocompatible material, .
- Are packaged using the same materials and processes. .

Summary of how the PrimaConnex Ceramic Abutment is substantially equivalent to the Astra Tech Implants - Dental System Ceramic Abutment (K023631):

- Have the same intended use, .
- Incorporate the identical biocompatible material, .
- Incorporate the same fundamental scientific technology. .

In summary, the PrimaConnex Ceramic Abutment described in this submission is, in our opinion, substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brain Smekal Regulatory Affairs Specialist Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318

NOV - 1 2006

Re: K062876

Trade/Device Name: PrimaConnex® Ceramic Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 20, 2006 Received: October 24, 2006

Dear Mr. Smekal:

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. Smekal

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/industry/support/index.html.

Sincerely yours,

Chiu Liu, Ph.D.

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 Statement

510(k) Number: K062876

Device Name: PrimaConnex® Ceramic Abutments

#### Indications for Use:

PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

Prescription Use X 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)

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