Home › Device types › NPL
Barrier, Animal Source, Intraoral
FDA product code NPL · Class 2 · Dental
515
Registered devices
191
Adverse events
11
Recalls
57
510(k) clearances
Devices with this code
X-FLEX — COLLAGEN MATRIX, INC.Neocirrus — Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.COVAMAX — DILON TECHNOLOGIES FRANCEbioMAINTAIN — COLLAGEN MATRIX, INC.COVAMAX — DILON TECHNOLOGIES FRANCEperFORM™ — ORTHOCELL LIMITEDMIS 4BONE — MIS Implants Technologies Ltd.OsseoGuard Flex — COLLAGEN MATRIX, INC.BioMend — COLLAGEN MATRIX, INC.SYMBIOS® — Dentsply Implants Manufacturing GmbHCyotplast™ RTM Collagen — Osteogenics Biomedical IncOUSIA bioADAPT — ACE SURGICAL SUPPLY CO., INC.X-FLEX — COLLAGEN MATRIX, INC.OSTEO-Flex — COLLAGEN MATRIX, INC.bioMAINTAIN — COLLAGEN MATRIX, INC.RCM6 Resorbable Collagen Membrane — ACE SURGICAL SUPPLY CO., INC.RCM6 Resorbable Collagen Membrane, RCP, NuOss, Conform — ACE SURGICAL SUPPLY CO., INC.Geistlich Fibro-Gide® — Geistlich Pharma AGMIS 4BONE — MIS Implants Technologies Ltd.OSTEO-Derm Enhanced — COLLAGEN MATRIX, INC.MatrixFlex — COLLAGEN MATRIX, INC.GIBSON HEALTHCARE — BENCO DENTAL SUPPLY CO.Zmatrix — Matricel GmbHMem-Lok — COLLAGEN MATRIX, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-03-19 | Collagen Matrix, Inc. | Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box |
| 2016-12-02 | Biom'up | Lack of sterility assurance |
| 2012-02-28 | Kensey Nash Corp | Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized produc |
| 2012-02-28 | Kensey Nash Corp | Recall 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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