Emdogain

• • Ongoing Z-0582-2026 FDA Class II ·initiated 17 Oct 2025

  The possibility for this product that is intended for demonstration purposes only to be placed in patients.

• 6 recalls, same reason

  • Terminated Z-1697-2018 FDA Class II ·initiated 23 Mar 2018
  • Terminated Z-1694-2018 FDA Class II ·initiated 23 Mar 2018
  • Terminated Z-1693-2018 FDA Class II ·initiated 23 Mar 2018
  • Terminated Z-1696-2018 FDA Class II ·initiated 23 Mar 2018
  • Terminated Z-1698-2018 FDA Class II ·initiated 23 Mar 2018
  • Terminated Z-1695-2018 FDA Class II ·initiated 23 Mar 2018

  A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.

Full name

Straumann Emdogain

Trade Name

Biora Emdogain(R)

Generic Name

Biologic material, dental

PMA Number

P930021 ↗

FDA Product Code

NQA

Device Class

Class III

Regulation

21 CFR Part 872.3930

Advisory Committee

Dental

FDA Decision

APPR Approved

• Iti Distance System

  Class II

  FDA 510(k) K931993 Active Cleared 26 Apr 1994

• Pre-Sterilized Iti Dental Implants

  Class II

  FDA 510(k) K920928 Active Cleared 15 Jul 1992

• Memfix

  Class II

  FDA 510(k) K955369 Active Cleared 23 Jan 1996

• Plastic Protection Healing Caps

  Class II

  FDA 510(k) K962023 Active Cleared 15 Aug 1996

• Endosseous Dental Implant & Accessories

  Class II

  FDA 510(k) K955281 Active Cleared 15 Mar 1996

• Iti Angled Abutment

  Class II

  FDA 510(k) K941393 Active Cleared 14 Jun 1995

See all devices from The Straumann Company →

• What is Straumann Emdogain used for in dental procedures and how does it work?

  Straumann Emdogain is a biologic dental material designed specifically for periodontal regeneration. It is a recombinant human enamel matrix derivative that supports tissue regeneration in periodontal and peri-implant defects by encouraging the formation of new cementum and periodontal ligament fibers. This helps restore damaged or lost periodontal structures, improving stability and function in affected areas.

• How is Straumann Emdogain supplied and what preparation is required before use?

  Straumann Emdogain is supplied as a lyophilized powder that must be reconstituted with sterile water for injection immediately before use. This preparation ensures the material is ready for application in dental procedures, and it is intended for single-use only to maintain sterility and clinical efficacy.

• Is Straumann Emdogain intended for reuse, or is it designed for single-use applications?

  Straumann Emdogain is explicitly designed for single-use applications in dental settings. The lyophilized powder and reconstitution process require immediate preparation before use, which aligns with single-use protocols to ensure sterility and patient safety.

• What regulatory approval does Straumann Emdogain hold, and how was it reviewed by the FDA?

  Straumann Emdogain holds FDA approval under the Premarket Approval (PMA) pathway, with PMA number P930021. It was reviewed by the FDA’s Dental (DE) Advisory Committee and received approval on September 30, 1996, following a standard review process (not expedited). The product is classified as a Class III device under the FDA’s regulatory framework.