Astra Tech Implants - Dental System Fixture OsseoSpeed; Dental System Fixture MicroMacro (new indication)

Astra Tech Implants - Dental System Fixture OsseoSpeed; Dental System Fixture MicroMacro (new indication)
Statement Letter:
Astra Tech,, Incorporated
C/O Mr. Bruce R. Manning
New England BioMedical Research, Incorporated
96 West Main Street
P.O. Box 809
Northborough, Massachusetts 01 532
Re: KO241 11
Trade/Device Name: Astra Tech Implants- Dental System Fixture OsseoSpeed
Dental System Fixture MicroMacro (new indication)
Regulation Number: 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: I11
Product Code: DZE
Dated: March 13,2003
Received: March 14,2003
Astra Tech Implants- Dental System Fixture MicroMarco
Dear Mr. Manning:
We have reviewed your Section 5 1 O(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 I1 (Special Controls) or class I11 (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.
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 (2 1 CFR Part 807); labeling (2 1 CFR Part 80 1); 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 53 1-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 5 1 O(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 (2 1 CFR Part 80 l), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification' (2 1 CFR 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. novlcdrhldsmddsmamain. html
Sincerely yours,
Susan Runner, DDS, MA
Interim Director
Division of Anesthesiology, General Hospital,
Office of Device Evaluation
Center for Devices and
Radiological Health
Summary Information:
Sponsor Name:
Astra Tech, Inc.
430 Bedford St, Suite 100
Lexington, MA 02240
Device Name
Proprietary Names:
Astra Tech Implants - Dental System Fixture OsseoSpeed
Astra Tech Implants - Dental System Fixture MicroMacro (new indication)
Common Name: Dental Implant
Classification name: Endosseous Dental Implant (21 CFR 872.3640)
Device Description
The Fixture OsseoSpeed is a root-form threaded dental implant made of Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.5, 4.0, 4.5 and 5.0 mm, and lengths from 8mm to 19mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delayed. Fixture MicroMacro is of similar design and construction and is available in diameters 3.5 and 4.0mm, and lengths from 8mm to 19mm.
Intended Use
The Fixture OsseoSpeed and Fixture MicroMacro are intended for endosseous implantation in the mandible and maxilla supporting single-tooth replacements, partial and total fixed/fixed detachable bridges and
overdentures. One or two stage surgical procedure can be used. When using the one stage surgical protocol, immediate loading may be applied in the anterior mandibular region (between the mental foramina) if at least four implants are splinted with a bar, or other continuous suprastructure.