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510(k) K090919

KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE by Kensey Nash Corp. — Product Code NPL

K090919 is an FDA 510(k) premarket notification submitted by Kensey Nash Corp. for the device "KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE". The FDA issued a decision of Substantially Equivalent on October 2, 2009. The device falls under product code NPL (Barrier, Animal Source, Intraoral), a Class II device regulated under 21 CFR 872.3930. Kensey Nash Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2009
Date Received
April 1, 2009
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 Kensey Nash Corp.

  • K103787 — MEDEOR MATRIX (February 7, 2011)
  • K091192 — KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX (November 2, 2009)
  • K091499 — MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) (October 22, 2009)
  • K073519 — QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 (March 28, 2008)
  • K071695 — KENSEY NASH MACROPORE SHIELD (December 31, 2007)
  • K072384 — MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE (September 21, 2007)
  • K072195 — THROMCAT THROMBECTOMY CATHETER SYSTEM (August 23, 2007)
  • K071237 — COPIOS BONE VOID FILLER SPONGE AND PASTE (June 1, 2007)
  • K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (October 20, 2006)
  • K061772 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM (July 11, 2006)

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