Alveoform Tm Biograft

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Implant, endosseous, root-form

PMA Number

P860012 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

APRL

• Qar Handpiece

  Class I

  FDA 510(k) K904671 Active Cleared 21 Dec 1990

• Dental Hand Instruments

  Class I

  FDA 510(k) K883322 Active Cleared 26 Aug 1988

• Osseodent Surgical Kit

  Class II

  FDA 510(k) K894331 Active Cleared 4 Oct 1989

• Osseotite Irrigation Unit

  Class I

  FDA 510(k) K901600 Active Cleared 21 Jun 1990

• Osseodent Dental Attachment, Igloo Magnet

  Class II

  FDA 510(k) K900275 Active Cleared 19 Apr 1990

• Osseodent(R) Precision Dental Attachments

  Class II

  FDA 510(k) K895463 Active Cleared 28 Mar 1990

See all devices from Collagen Corp. →

• What is the Alveoform Tm Biograft used for?

  The Alveoform Tm Biograft is an implant, endosseous, root-form device designed for dental applications, intended to be used as a root-form implant in dental procedures.

• How is the Alveoform Tm Biograft supplied?

  The device is supplied as a sterile, single-use implant, meaning it comes in a sterile condition and is designed for one-time use only.

• What is the regulatory status of the Alveoform Tm Biograft?

  The device is authorized under FDA PMA number P860012 with a product code DZE, and was approved on October 28, 1988 for dental use.

• Is the Alveoform Tm Biograft reusable?

  No, the Alveoform Tm Biograft is supplied as a single-use implant and should not be reused for patient safety reasons.