Astra Tech Implants Dental System

Astra Tech Implants Dental System
Statement Letter:
Astra Tech, Incorporated
CdO Mr. Bruce R. Manning
New England Biomedical Research, Incorporated
96 West Main Street
P.O. Box 809
Nortliborough, Massachusetts 01532
Re: K04l492
Trade/Device Name: Astra Tech Implants - Dental System
Regulation Number: 21 CFR 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: LI
Product Code: DZE
Dated: June 3, 2004
Received: June 4, 2004
Dear Mr. Manning:
We have reviewed your Section 5 10(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 Ill (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 2 1, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu aLin, Ph.D. S:
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Summary Information:
Submitter's Name: Astra Tech, Inc.
Submitter's Adress: (US Representative)
Astra Tech Inc.
890 Winter Street, Suite 310
Waltham, MA 02451-1493
781-890-6800 phone
781-890-6808 fax
Contact's names and Niklas Lidskog, President, 781-890-6800
Telephone numbers: Ann-Mari Eriksson, Manager Regulatory Affairs
+46-31-776-3000.
Bruce Manning, Consultant, New England
Biomedical Research, 508-393-3100
Date Prepared: May 2004
Address (Manufacturer) Astra Tech AB
P.O Box 14
SE-431-21 Mblndal
Sweden
Device name Proprietary name: Astra Tech Implants-Dental System, Immediate function
Common name: Dental implant
Classification name: Endosseous Dental Implant
Description of Device
The Astra Tech Dental Implants are root-formed threaded screws made from commercially pure titanium.
The indications and use for the components are not different from similar components of the predicate device.
Intended Use
This application provides for revision of Astra Tech Dental Implants labeling allowing the option of immediate function. The intended use for this device is to provide support for prosthetic constructions for fully' and partially edentulous arches using one or two stage surgical procedures.