FDA Device Intelligence
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Barrier, Animal Source, Intraoral

FDA product code NPL · Class 2 · Dental

521
Registered devices
191
Adverse events
11
Recalls
57
510(k) clearances

Devices with this code

OssGuide — HYUNDAI BIOLAND Co., Ltd.OsseoGuard Flex — COLLAGEN MATRIX, INC.Endoform™ Dental Membrane — AROA BIOSURGERY LIMITEDBicon Resorbable Collagen Membrane — COLLAGEN MATRIX, INC.PuraEXTEND — COLLAGEN MATRIX, INC.MaxxDerm — COLLAGEN MATRIX, INC.MaxxDerm+ — COLLAGEN MATRIX, INC.OUSIA bioADAPT — ACE SURGICAL SUPPLY CO., INC.GIBSON HEALTHCARE — BENCO DENTAL SUPPLY CO.Geistlich Mucograft® Seal — Geistlich Pharma AGGeistlich Mucograft® — Geistlich Pharma AGNeogen Collagen Firm M — COLLAGEN MATRIX, INC.X-FLEX — COLLAGEN MATRIX, INC.bioMAINTAIN — COLLAGEN MATRIX, INC.GEM™ Synthetic Bone Graft — LYNCH BIOLOGICS, LLCOSSIX® VOLUMAX — DATUM DENTAL LTDZmatrix — Matricel GmbHCYTOPLAST RTM COLLAGEN — Osteogenics Biomedical IncCyotplast™ RTM Collagen — Osteogenics Biomedical IncDynaMatrix Plus — COOK BIOTECH INCORPORATEDOUSIA bioADAPT — ACE SURGICAL SUPPLY CO., INC.AmpliDerm — COLLAGEN MATRIX, INC.GENOSS Collagen Membrane — GENOSS CO., Ltd.CopiOs Extend — COLLAGEN MATRIX, INC.

Recent recalls

DateFirmReason
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-11-05Collagen Matrix IncThe products may have been packaged with an incorrect Instructions for Use.
2019-03-19Collagen Matrix, Inc.Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
2016-12-02Biom'upLack of sterility assurance
2012-02-28Kensey Nash CorpRecall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized produc
2012-02-28Kensey Nash CorpRecall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized produc

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.