CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS

K083496 · Altatec GmbH · DZE · Jan 30, 2009 · Dental

Device Facts

• Record ID: K083496
• Device Name: CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS
• Applicant: Altatec GmbH
• Product Code: DZE · Dental
• Decision Date: Jan 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Camlog Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Camlog Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Device Story

CAMLOG Implant System consists of threaded root-form dental implants and abutments; used to support prosthetic restorations (crowns, bridges, overdentures) in edentulous or partially edentulous patients. Implants placed in maxillary or mandibular bone; surgical procedure performed by dental professionals. System includes laboratory copings, impression copings, and analogs to facilitate prosthetic preparation. Implants allow for immediate or delayed placement; immediate loading possible if primary stability is achieved. Device provides structural foundation for dental prosthetics, restoring oral function and aesthetics.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarities to legally marketed predicate devices. Bench testing only.

Technological Characteristics

Threaded root-form dental implants and abutments. Materials and sterilization processes are consistent with legally marketed predicate devices. System includes various sizes and prosthetic components (copings, analogs).

Indications for Use

Indicated for edentulous or partially edentulous patients requiring dental implants for support of crowns, bridges, or overdentures in the maxillary or mandibular arch. Implants may be placed immediately post-extraction or after a healing period.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Submission Summary (Full Text)

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510(k) Summary

K683496

CAMLOG Implant System

# 510(k) Summary

#### Altatec GmbH JAN 3 0 2009 CAMLOG Implant System Modified Implants and Abutments

#### ADMINISTRATIVE INFORMATION

Manufacturer Name:

Altatec GmbH Maybachstrasse 5 D-71299 Wimsheim, Germany Telephone: [phone] Fax: [phone]

Telephone: [phone]

Tina Steffanie-Oak CAMLOG USA

Fax: [phone]

Official Contact:

Representative/Consultant:

Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA USA 92130 Telephone: [phone] Fax: [phone] Email: [e-mail] [e-mail]

Email: [e-mail]

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:

Common Name: Classification Regulations:

Product Codes Classification Panel: Reviewing Branch:

CAMLOG Implant System Modified Implants and Abutments Dental implant; Dental implant abutment Implant, endosseous, root-form; Endosseous dental implant abutment 21 CFR 872.3640; 21 CFR 872.3630 DŻE, NHA Dental Products Panel Dental Devices Branch

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K083496

510(k) Summary

CAMLOG Implant System

## INTENDED USE

Camlog Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Camlog Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

#### DEVICE DESCRIPTION

The Camlog Implant System includes various sizes of threaded root-form dental implants and abutments intended to support prosthetic restorations in edentulous or partially edentulous patients. The implants can be placed immediately following extraction or after a healing period. If good primary stability is reached the implants may be immediately loaded. The complete system includes a variety of laboratory (burnout) copings, impression copings, analogs and other components intended to facilitate the preparation of prosthetic restorations.

#### EQUIVALENCE TO MARKETED PRODUCT

The components of the CAMLOG Implant System, including the modified implants and abutments, have the same basic design as the predicate devices. Overall, the CAMLOG Implant System has the following similarities to the predicate devices:

- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design.
- · incorporates the same materials, and
- · has similar packaging and is sterilized using the same materials and processes.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Altatec GmbH C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

JAN 3 0 2009

Re: K083496

> Trade/Device Name: CAMLOG Implant System Modified Implants and Abutments Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 21, 2008 Received: November 25, 2008

Dear Ms. Schulz:

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. Schulz

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Antimony Donaton Jr.
Curtis V. Mitchell, M.D.

Ginette Y. Michaud, M. Acting 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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K083496

510(k) Premarket Notification

CAMLOG Implant System

9 ી,

## Indications for Use

510(k) Number (if known):

Device Name: CAMLOG Implant System Modified Implants and Abutments

Indications for Use:

Camlog Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Camlog Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

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
510(k) Number: K083496
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