Product Code: NPL
FDA class 2
21 CFR 872.3930
Barrier, Animal Source, Intraoral
Dental
The animal-source intraoral barrier is a dental implant device made of animal-derived materials such as collagen, intended to aid in guided tissue and bone regeneration procedures and to act as a stable barrier for containment of bone graft materials around implants. It is classified as FDA Class 2 under regulation 872.3930 in the Dental specialty, requiring 510(k) clearance, and carries an implant flag. Product code NPL is not eligible for third-party review.
510(k)s
53
FEI Numbers
60
Registration Numbers
60
Unique Applicants
32
Years Active
24
Basic Information
- Product Code
- NPL
- Device Class
- FDA class 2
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
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.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 53 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250833 | SwissMembrane X; SwissMembrane X Socket | Apr 15, 2025 | Substantially Equivalent | Geistlich Pharma AG |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | May 01, 2024 | Substantially Equivalent | Collagen Matrix, Inc. |
| K231513 | Oral Matrix | Feb 16, 2024 | Substantially Equivalent | Beijing Biosis Healing Biological Technology Co., Ltd. |
| K231305 | Endoform Dental Membrane | Jan 23, 2024 | Substantially Equivalent | Aroa Biosurgery Ltd. |
| K230091 | THE Cover | Oct 06, 2023 | Substantially Equivalent | Purgo Biologics Inc. |
| K223912 | InterCollagen® Guide | Aug 17, 2023 | Substantially Equivalent | SigmaGraft Inc. |
| K213904 | Kerecis Oral | Sep 30, 2022 | Substantially Equivalent | Kerecis |
| K212509 | OSSIX Breeze | Jul 18, 2022 | Substantially Equivalent | Datum Dental Ltd. |
| K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack | Apr 05, 2022 | Substantially Equivalent | Geistlich Pharma AG |
| K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Mar 03, 2021 | Substantially Equivalent | Geistlich Pharma AG |
| K201241 | Striate+ | Jan 11, 2021 | Substantially Equivalent | Orthocell Ltd |
| K192612 | Kerecis Gingiva Graft | Nov 13, 2020 | Substantially Equivalent | Kerecis Limited |
| K200623 | OssGuide | Oct 02, 2020 | Substantially Equivalent | Sk bioland Co., Ltd. |
| K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal | Aug 29, 2019 | Substantially Equivalent | Geistlich Pharma AG |
| K173562 | Straumann Jason Membrane | Jul 09, 2018 | Substantially Equivalent | Institut Straumann AG |
| K171050 | Geistlich Fibro-Gide | Nov 09, 2017 | Substantially Equivalent | Geistlich Pharma AG |
| K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed | Oct 30, 2017 | Substantially Equivalent | Geistlich Pharma AG |
| K161762 | DynaMatrix/Dynamatrix Plus | Jan 13, 2017 | Substantially Equivalent | COOK BIOTECH INCORPORATED |
| K160281 | OSSIX PLUS | Aug 04, 2016 | Substantially Equivalent | Datum Dental Ltd. |
| K153549 | OSSIX VOLUMAX | Aug 04, 2016 | Substantially Equivalent | Datum Dental Ltd. |
| K160474 | DSM Biomedical Porcine Pericardium Dental Membrane | Jun 07, 2016 | Substantially Equivalent | Kensey Nash Corporation dba DSM Biomedical |
| K141177 | VITALA PORCINE DERIVED COLLAGEN MEMBRANE | Sep 15, 2015 | Substantially Equivalent | OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI |
| K142496 | Collagen Dental Membrane - Conformable IIBP | Nov 24, 2014 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | Nov 05, 2014 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K133507 | GUIDOSS | Nov 05, 2014 | Substantially Equivalent | NIBEC CO LTD |
| K140518 | GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER | Jul 18, 2014 | Substantially Equivalent | GEISTLICH PHARMA AG |
| K123697 | MATRICEL DENTAL BARRIER MEMBRANE | Feb 24, 2014 | Substantially Equivalent | MATRICEL GMBH |
| K121310 | MESOTHELIUM DENTAL MEMBRANE | Jul 11, 2013 | Substantially Equivalent | KENSEY NASH CORPORATION |
| K100695 | COLLADENTAL BARRIER | Jan 03, 2013 | Substantially Equivalent | COLLAMATRIX, INC |
| K103087 | COVAMAX RESORBABLE COLLAGEN MEMBRANE | Aug 26, 2011 | Substantially Equivalent | BIOM'UP SAS |
| K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | Jul 29, 2011 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K101453 | VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE | Jul 21, 2011 | Substantially Equivalent | OBI BIOLOGICS, INC. |
| K102307 | GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS | May 04, 2011 | Substantially Equivalent | GENOSS CO., LTD. |
| K102531 | MUCOGRAFT | Nov 17, 2010 | Substantially Equivalent | ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE |
| K100156 | COLLAGEN DENTAL MEMBRANE V | Aug 11, 2010 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K091192 | KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX | Nov 02, 2009 | Substantially Equivalent | KENSEY NASH CORP. |
| K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE | Oct 02, 2009 | Substantially Equivalent | KENSEY NASH CORP. |
| K090216 | COLLAGEN DENTAL MEMBRANE IV | Sep 18, 2009 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K082058 | DYNAMATRIX | Oct 02, 2008 | Substantially Equivalent | COOK BIOTECH, INC. |
| K073685 | OTA COLLAGEN BIOMATERIAL | Aug 29, 2008 | Substantially Equivalent | OSSEOUS TECHNOLOGIES OF AMERICA |
| K073711 | MUCOGRAFT COLLAGEN MATRIX | May 30, 2008 | Substantially Equivalent | ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
| K073097 | TUTODENT DENTAL MEMBRANE | May 12, 2008 | Substantially Equivalent | TUTOGEN MEDICAL U.S., INC. |
| K071555 | FORTAGEN ORAL MEMBRANE | Aug 30, 2007 | Substantially Equivalent | ORGANOGENESIS, INC. |
| K062846 | COLLAGEN DENTAL MEMBRANE III | Oct 13, 2006 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K062881 | COLLAGEN DENTAL MENBRANE - CONFORMABLE II | Oct 11, 2006 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K061244 | MUCOGRAFT | Jun 06, 2006 | Substantially Equivalent | ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
| K053260 | OSSIX -PLUS | Feb 22, 2006 | Substantially Equivalent | COLBAR LIFESCIENCE LTD. |
| K050446 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE | Aug 09, 2005 | Substantially Equivalent | ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
| K042197 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION | Nov 15, 2004 | Substantially Equivalent | ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
| K012423 | MUCOGRAFT | Jan 24, 2003 | Substantially Equivalent | ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
| K010952 | SURGISIS GUIDED TISSUE REGENERATION MATRIX | Jun 10, 2002 | Substantially Equivalent | COOK BIOTECH, INC. |
| K011695 | COLLAGEN DENTAL MEMBRANE | Aug 07, 2001 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K003339 | COLLAGEN PERIODONTAL MEMBRANE | Jan 08, 2001 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
FEI Numbers
This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.