CAMLOG ABUTMENTS PS

K090347 · Altatec GmbH · NHA · Jun 18, 2009 · Dental

Device Facts

• Record ID: K090347
• Device Name: CAMLOG ABUTMENTS PS
• Applicant: Altatec GmbH
• Product Code: NHA · Dental
• Decision Date: Jun 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

CAMLOG® Abutments PS are 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

CAMLOG® Abutments PS are dental implant abutments designed for use with CAMLOG dental implants. The system utilizes a 'Platform Switching' design, featuring an abutment interface diameter smaller than the implant platform diameter. Components include permanent abutments, temporary abutments, and healing caps. Used by dental professionals to fabricate crowns and bridges to support prostheses in the maxillary or mandibular arch. The device functions as a mechanical interface between the endosseous implant and the final dental restoration.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Endosseous dental implant abutment; Platform Switching design; includes permanent/temporary abutments and healing caps. Materials, design, and sterilization processes are consistent with predicate devices.

Indications for Use

Indicated for patients requiring dental prostheses 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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## 510(k) Summary

# Altatec GmbH CAMLOG® Abutments PS

JUN 18 2009

### ADMINISTRATIVE INFORMATION

Manufacturer-Name:

Official Contact:

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

Tina Steffanie-Oak CAMLOG USA Telephone: [phone] Fax: [phone] Email: [e-mail]

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]

### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Representative/Consultant:

Product Code: Classification Panel: Reviewing Branch:

CAMLOG® Abutments PS Dental implant abutments Endosseous dental implant abutment 21 CFR 872.3630, Class II NHA Dental Products Panel Dental Devices Branch

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#### 510(k) Summary

### INTENDED USE

CAMLOG® Abutments PS are 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 Implant System CAMLOG Abutments PS (Platform Switching) allows the treatment option of using a smaller abutment interface diameter than the platform diameter of the implant. The system includes a series of permanent abutments, temporary abutments and healing caps.

#### EQUIVALENCE TO MARKETED PRODUCT

Altatec GmbH demonstrated that, for the purposes of FDA's regulation of medical devices, CAMLOG Abutments PS are 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.

Overall, the CAMLOG Abutments PS have the following similarities to the predicate devices:

- I use the same operating principle,
- incorporate the same basic design,
- I incorporate the same materials, and
- 트 are packaged and sterilized using the same materials and processes.

In summary, CAMLOG Abutments PS described in this submission are, in our opinion, substantially equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUN 18 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090347

Trade/Device Name: CAMLOG® Abutments PS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 26, 2009 Received: May 27, 2009

#### 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers Offices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Susan Punner

Susan Runner, D.D.S., M.A. Acting Division 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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510(k) Summary

# Indications for Use

510(k) Number (if known):

CAMLOG® Abutments PS Device Name:

Indications for Use:

CAMLOG® Abutments PS are 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.

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)

| | Kei Harley for VSC |
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| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |

| 510(k) Number: | K090347 |
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