DynaMatrix

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

510(k) Number

K082058 ↗

FDA Product Code

NPL

Device Class

Class II

Regulation

21 CFR Part 872.3930

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Hybrid Graft

  Class II

  FDA 510(k) K111695 Active Cleared 2 Apr 2012

• Sis Fistula Plug

  Class II

  FDA 510(k) K050337 Active Cleared 9 Mar 2005

• Surgisis Staple Line Reinforcement II

  Class II

  FDA 510(k) K051048 Active Cleared 23 Sep 2005

• Surgisis Rvp Recto-Vaginal Fistula Plug Open recall

  Class II

  FDA 510(k) K062729 Active Cleared 10 Oct 2006

• Oasis Wound Matrix

  Unclassified

  FDA 510(k) K061711 Active Cleared 19 Jul 2006

• Surgisis Staple Line Reinforcement

  Class II

  FDA 510(k) K022044 Active Cleared 23 Aug 2002

See all devices from Cook Biotech, Inc. →

• What is DynaMatrix used for?

  DynaMatrix is a multi-purpose surgical mesh made of collagen and is bioabsorbable. It is classified as a barrier device of animal source intended for intraoral use in dental surgical procedures.

• Is DynaMatrix sterile or non-sterile when supplied?

  DynaMatrix is supplied non-sterile, as stated in the device specifications, and is intended for single use in dental surgical procedures.

• Can DynaMatrix be reused after a procedure?

  DynaMatrix is intended for single use only, as specified in the device description, and should not be reused due to its bioabsorbable nature and design for one-time intraoral application.

• What regulatory pathway was used for DynaMatrix?

  DynaMatrix received FDA 510(k) clearance (K082058) on October 2, 2008, and is classified as a Class II medical device under the traditional clearance pathway.

• What is the product code for DynaMatrix in the FDA database?

  The product code for DynaMatrix is NPL, as listed in the device data under the product_code field.