PRIMACONNEX CAD/CAM ABUTMENT SYSTEM

K072241 · Lifecore Biomedical, Inc. · NHA · Nov 9, 2007 · Dental

Device Facts

• Record ID: K072241
• Device Name: PRIMACONNEX CAD/CAM ABUTMENT SYSTEM
• Applicant: Lifecore Biomedical, Inc.
• Product Code: NHA · Dental
• Decision Date: Nov 9, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lifecore PrimaConnex CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. They are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae in the construction of single-unit cement retained restorations on Lifecore PrimaConnex CAD/CAM Abutments.

Device Story

System consists of CAD/CAM-milled abutments and ceramic copings; used as accessories to Lifecore PrimaConnex endosseous implants. Computer-assisted technology enables custom milling of abutments to match patient-specific anatomic geometry. Abutments secure to implants via screws; support cement-retained prosthetic restorations. Used by dental professionals in clinical settings to restore function in edentulous patients. Output is a patient-specific prosthetic foundation; aids clinicians in achieving optimal fit and support for dental crowns/bridges. Benefits include improved anatomical adaptation and prosthetic stability.

Clinical Evidence

Bench testing only. Static and dynamic fatigue testing performed to evaluate mechanical integrity of the abutment system.

Technological Characteristics

CAD/CAM-milled abutments and ceramic copings. Custom geometry based on patient anatomy. Designed for cement-retained restorations. Mechanical fixation via abutment screw to endosseous implant.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic restorations in the mandible or maxilla, supported by Lifecore PrimaConnex endosseous 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

• DDS-ZR Zirconia (DDS Services) (K041645)
• PrimaConnex Implant System (Lifecore Biomedical, Inc.) (K051614)
• Atlantis Components' Abutment for Zimmer Internal Connection (Atlantis Components, Inc.) (K053373)
• PrimaConnex Ceramic Copings (Lifecore Biomedical, Inc.) (K060530)
• Atlantis Components' Abutment for Astra Implant (Atlantis Components, Inc.) (K070833)

Submission Summary (Full Text)

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K072241

# 510(k) SUMMARY AND CERTIFICATION [As required by 21 CFR 807.92(c)]

| 1. Submitter's Name and Contact Person | | NOV 9 2007 |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------|
| Lifecore Biomedical, Inc.<br>3515 Lyman Blvd<br>Chaska, MN 55318 | Judith Medlock-Hayes<br>Regulatory Affairs Specialist<br>Ph: 952.368.6364; Fax: [phone] | |

#### 2. General Information

| Trade Name | Lifecore PrimaConnex® CAD/CAM<br>Abutment System |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Endosseous dental implant abutment<br>Ceramic Coping |
| Classification Name | Abutment: Endosseous dental implant<br>abutment<br>21 CFR §872.3630,<br>Coping: Porcelain Tooth<br>21 CFR §872.3290 |
| Product Code | NHA, ELL |
| Identification of Predicate Devices | DDS-ZR Zirconia (DDS Services) (K041645) PrimaConnex Implant System<br>(Lifecore Biomedical, Inc.) (K051614) Atlantis Components' Abutment for<br>Zimmer Internal Connection (Atlantis<br>Components, Inc.) (K053373) PrimaConnex Ceramic Copings<br>(Lifecore Biomedical, Inc.) (K060530) Atlantis Components' Abutment for<br>Astra Implant (Atlantis Components,<br>Inc.) (K070833) |

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### 3. Device Description

The PrimaConnex CAD/CAM Abutments and abutment-specific ceramic copings are placed onto the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The abutments and copings are milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry to meet individual anatomic variations in patient tooth and jaw structure.

### 4. Intended Use

The Lifecore PrimaConnex CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. They are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae in the construction of single-unit cement retained restorations on Lifecore PrimaConnex CAD/CAM Abutments.

## 5. Substantial Equivalence Comparison

The PrimaConnex CAD/CAM Abutment System and predicate devices are substantially equivalent in intended use, material composition, fundamental scientific technology, principles of operation, and basic design. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaConnex CAD/CAM Abutment System.

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## Summary of Attachments

| Attachment A: | Device and Accessory Drawings |
|---------------|----------------------------------------------------------------------------------------------------------------------|
| Attachment B: | Static and Dynamic Fatigue Testing of Endosseous Dental<br>Implant Systems – PrimaConnex® CAD/CAM Abutment<br>System |
| Attachment C: | Predicate Device Information |
| Attachment D: | Declaration of Conformity |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of a human figure with three arms or lines extending from the head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

Ms. Judith Medlock-Hayes Regulatory Affairs Specialist Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318

Rc: K072241

Trade/Device Name: PrimaConnex® CAD/CAM Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA, ELL Dated: August 10, 2007 Received: August 13, 2007

Dear Ms. Medlock-Hayes:

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. Clement

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.

Nail R. Qghn
Chiu Lin, Ph.D.,

hiu 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

### 510(k) Number (if known):

Device Name: PrimaConnex® CAD/CAM Abutment System

#### Indications for Use:

The Lifecore PrimaConnex® CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae in the construction of single-unit cement retained restorations on Lifecore PrimaConnex CAD/CAM Abutments.

Prescription Use _X__________ AND/OR

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runns

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

510(k) Number: K072241