ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT

K072624 · Astra Tech AB · NHA · Oct 1, 2007 · Dental

Device Facts

• Record ID: K072624
• Device Name: ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
• Applicant: Astra Tech AB
• Product Code: NHA · Dental
• Decision Date: Oct 1, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Astra Tech Implant System abutments are intended to be used in conjunction with Astra Tech Implant System implants in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

Device Story

The Astra Tech Implant System is a dental implant abutment system. This modification adds a new abutment component for provisional restorations. The device is used by dental professionals in a clinical setting to support prosthetic restorations (crowns, bridges, overdentures) attached to endosseous dental implants. The abutment serves as the interface between the implant and the final or provisional restoration. By providing a stable connection, it enables the restoration of function and aesthetics for edentulous or partially edentulous patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarities to the existing, legally marketed Astra Tech Implant System.

Technological Characteristics

Endosseous dental implant abutment. Materials and manufacturing processes are identical to the existing Astra Tech Implant System. No software or electronic components.

Indications for Use

Indicated for patients with fully or partially edentulous maxillary and/or mandibular arches requiring support for crowns, bridges, or overdentures.

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)

{0}------------------------------------------------

KC72624

1/2

510(k) Summary

Astra Tech Implant System, New Component

# 510(k) Summary

OCT 1 2007

# Astra Tech AB Special 510(k): Device Modification

## Astra Tech Implant System, New Component

### ADMINISTRATIVE INFORMATION

Manufacturer Name:

Astra Tech AB Aminogatan 1, P.O. Box 14 Mölndal, Sweden SE-431-21 Telephone: [phone] Fax: [phone]

Official Contact:

Representative/Consultant:

Christina Lewing

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

## DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Name:

Product Code: Classification Panel: Reviewing Branch:

Astra Tech Implant System, New Component Endosseous dental implant abutment Abutment, Implant, Dental, Endosseous (21 CFR 872.3630), Class II NHA Dental Products Dental Devices

### INTENDED USE

Astra Tech Implant System abutments are intended to be used in conjunction with Astra Tech Implant System implants in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

{1}------------------------------------------------

K072624

2 of 2

510(k) Summary

Astra Tech Implant System, New Component

## DEVICE DESCRIPTION

The Astra Tech Implant System has been modified to increase treatment options by adding a new component, an additional abutment for provisional restorations.

### EQUIVALENCE TO MARKETED PRODUCT

The modified Astra Tech Implant System has the following similarities to the unmodified predicate Astra Tech Implant System:

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

In summary, the modification to the Astra Tech Implant System described in this submission is, in our opinion, substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Astra Tech AB C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, L.L.C. 11234 El Camino Real, Suite 200 San Diego, California 92130

OCT 1 2007

Re: K072624

Trade/Device Name: Astra Tech Implant System, New Component Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 13, 2007 Received: September 17, 2007

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.

{3}------------------------------------------------

#### 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 (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 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,

Syrite Y. Michael Ows

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

{4}------------------------------------------------

K072624

1071

Special 510(k): Device Modification

Astra Tech Implant System, New Component

## Indications for Use

510(k) Number (if known):

Device Name:

Astra Tech Implant System, New Component

Indications for Use:

Astra Tech Implant System abutments are intended to be used in conjunction with Astra Tech Implant System implants in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(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 Page 1 of _______
Infection Control, Dental Devices

| 510(k) Number: | K072624 |
|----------------|---------|
|----------------|---------|

Page 14 of 80