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510(k) K082058

DYNAMATRIX by Cook Biotech, Inc. — Product Code NPL

K082058 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "DYNAMATRIX". The FDA issued a decision of Substantially Equivalent on October 2, 2008. The device falls under product code NPL (Barrier, Animal Source, Intraoral), a Class II device regulated under 21 CFR 872.3930. Cook Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2008
Date Received
July 21, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Barrier, Animal Source, Intraoral
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.

Other clearances by Cook Biotech, Inc.

  • K133306 — SIS HERNIA GRAFT (July 23, 2014)
  • K133011 — DIAPHRAGMATIC HERNIA GRAFT (June 20, 2014)
  • K131015 — BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT (October 8, 2013)
  • K111695 — HYBRID GRAFT (April 2, 2012)
  • K110402 — BIODESIGN NIPPLE RECONSTRUCTION CYLINDER (June 20, 2011)
  • K090688 — COOK UROLOGICAL GRAFT (July 10, 2009)
  • K082682 — SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG (February 27, 2009)
  • K073391 — SURGISIS BIODESIGN TISSUE GRAFT (March 21, 2008)
  • K070405 — MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT (October 17, 2007)
  • K070738 — SIS FACIAL CYLINDER, SIS FACIAL IMPLANT (April 5, 2007)

Other clearances for product code NPL

  • K242817 — Jason membrane (December 12, 2025)
  • K250512 — Augmented Gingival Matrix (December 5, 2025)
  • K252253 — Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® (November 25, 2025)
  • K251062 — Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; G (August 14, 2025)
  • K250833 — SwissMembrane X; SwissMembrane X Socket (April 15, 2025)
  • K233203 — Soft Tissue Augmentation Resorbable Matrix (May 1, 2024)
  • K231513 — Oral Matrix (February 16, 2024)
  • K231305 — Endoform Dental Membrane (January 23, 2024)
  • K230091 — THE Cover (October 6, 2023)
  • K223912 — InterCollagen® Guide (August 17, 2023)

FDA data resources