ALTATEC CERAMIC ABUTMENT

K032448 · Altatec Biotechnologies · NHA · Aug 22, 2003 · Dental

Device Facts

• Record ID: K032448
• Device Name: ALTATEC CERAMIC ABUTMENT
• Applicant: Altatec Biotechnologies
• Product Code: NHA · Dental
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ALTATEC BIOTECHNOLOGIES implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila. The Ti-Ceramic abutment is used with the mentioned implant supported restorations where high aesthetics are desired.

Device Story

ALTATEC Camlog Implant System consists of endosseous dental implants and abutments; used for tooth replacement and prosthetic support. Implants surgically placed in mandible or maxilla; abutments attached to implants to support crowns, bridges, or overdentures. Ti-Ceramic abutments utilized for high-aesthetic requirements. System provides structural foundation for dental restorations; enables functional and aesthetic rehabilitation of edentulous or partially edentulous patients. Operated by dental professionals in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Endosseous dental implant system; includes implants and abutments. Materials include titanium and ceramic (Ti-Ceramic abutments). Designed for surgical implantation into the jawbone to support dental prosthetics.

Indications for Use

Indicated for patients requiring single tooth replacement, fixed bridgework (long span or free-end edentulous), overdentures, or full arch fixed prostheses in totally or partially edentulous mandibles or maxillae.

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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Public Health Service

AUG 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Altatec Biotechnologies C/O Mr. Robert Joel Slomoff 9229 Cranford Drive Potomac, Maryland 20854

Re: K032448

Trade/Device Name: ALTATEC Camlog Implant System and Abutments Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: August 7, 2003 Received: August 8, 2003

Dear Mr. Slomoff:

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. Slomoff

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 (OS) 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 vou 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/dsma/dsmamain.html

Sincerely yours,

Susan Burns

Susan Runner, DDS, MA Interim 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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Pending KO32448 510k Number

Device Name: ALTATEC Camlog Implant System and Abutments

## INDICATIONS:

ALTATEC BIOTECHNOLOGIES implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.

The Ti-Ceramic abutment is used with the mentioned implant supported restorations where high aesthetics are desired.

Concurrance of CDRH

Office of Device Evaluation (ODE)

Kein Mulvey for MSR

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

K 032448