CAMLOG LOGFIT PROSTHETIC SYSTEM

K071213 · Altatec GmbH · NHA · Aug 10, 2007 · Dental

Device Facts

• Record ID: K071213
• Device Name: CAMLOG LOGFIT PROSTHETIC SYSTEM
• Applicant: Altatec GmbH
• Product Code: NHA · Dental
• Decision Date: Aug 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAMLOG Logfit™ Prosthetic System is intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.

Device Story

System comprises dental implant abutments and screws; used to support cement-retained crowns and bridges on CAMLOG dental implants. Components include impression caps, analogs, and burn-out copings to facilitate prosthetic restoration preparation. Used in dental clinics by dentists/prosthodontists. Abutments connect to implants to provide stable foundation for final prosthetic restorations. Benefits include restoration of dental function and aesthetics for patients requiring tooth replacement.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dental implant abutments and screws; includes impression caps, analogs, and burn-out copings. Designed for use with CAMLOG dental implants. Mechanical system for prosthetic support.

Indications for Use

Indicated for patients requiring dental crown or bridge restorations supported by CAMLOG dental implants in the maxillary or mandibular arch.

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.)

Submission Summary (Full Text)

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# K071213

# 510(k) Summary

# CAMLOG Logfit™ Prosthetic System

AUG 1 0 2007

### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Altatec GmbH<br>Maybachstrasse 5<br>D-71299 Wimsheim, Germany<br>Telephone [phone]<br>Fax [phone] |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Tina Steffanie-Oak<br>CAMLOG USA<br>Telephone [phone] x4150<br>Fax [phone]<br>email: [e-mail] |
| Representative/Consultant: | Floyd G. Larson<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200<br>San Diego, CA 92130<br>Telephone [phone]<br>Fax [phone]<br>email: [e-mail] |

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | CAMLOG Logfit™ Prosthetic System |
|----------------------------|-------------------------------------------------------------------|
| Common Name: | dental abutments |
| Classification Regulation: | Endosseous dental implant abutment<br>(21 CFR 872.3630), Class II |
| Product Codes | NHA |

# DEVICE CLASSIFICATION PANEL

The Classification Panel for this device is the Dental Products Panel, and it is reviewed by the Dental Devices Branch.

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#### INTENDED USE

KC 71213

The CAMLOG Logfit™ Prosthetic System is intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.

# DEVICE DESCRIPTION

The CAMLOG Logfit Prosthetic System includes dental implant abutments and screws intended to be used to support cement retained crowns and bridges in conjunction with Camlog dental implants in the maxillary and/or mandibular arch. The system also includes impression caps, analogs and plastic, burn-out copings, (Class I exempt, not a part of this submission), intended to facilitate the preparation of prosthetic restorations.

# EQUIVALENCE TO MARKETED PRODUCT

Altatec GmbH has demonstrated that, for the purposes of FDA's regulation of medical devices, the CAMLOG Logfit Prosthetic System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 0 2007

Altatec GmbH Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K071213

Trade/Device Name: CAMLOG Logfit™ Prosthetic System Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 30, 2007 Received: July 31, 2007

Dear Mr. Larson:

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. Larson

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.

Clare

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

510(k) Number (if known): _ КО 7 121 3

Device Name: CAMLOG Logfit™ Prosthetic System

Indications for Use:

The CAMLOG Logfit™ Prosthetic System is intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the naxillary and/or mandibular arch.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

E10(k) Number: K071213