Barrier, Animal Source, Intraoral
Regulation 872.3930
3510(k)s in 12 months (57 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in NPL
| Company | 510(k)s | Recalls |
|---|---|---|
| Collagen Matrix, Inc. | 10 | 7 |
| Geistlich Pharma AG | 9 | 0 |
| Kensey Nash Corp. | 3 | 3 |
| Ed. Geistlich Soehne AG Fuer Chemische Industrie | 5 | 0 |
| Cook Biotech Incorporated | 3 | 0 |
| Datum Dental, Ltd. | 3 | 0 |
| Biom'Up Sas | 1 | 1 |
| Kerecis | 2 | 0 |
| Aroa Biosurgery , Ltd. | 1 | 0 |
| Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2019 | Collagen Matrix Inc GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around impla Terminated |
NPL | K100156 |
| Nov 5, 2019 | Collagen Matrix Inc GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around impla Terminated |
NPL | K100156 |
| Nov 5, 2019 | Collagen Matrix Inc GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around imp Terminated |
NPL | K100156 |
| Nov 5, 2019 | Collagen Matrix Inc GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants p Terminated |
NPL | K100156 |
| Nov 5, 2019 | Collagen Matrix Inc GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants p Terminated |
NPL | K100156 |
| Nov 5, 2019 | Collagen Matrix Inc GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants p Terminated |
NPL | K100156 |
| Mar 19, 2019 | Collagen Matrix, Inc. Neomem Resorbable Collagen Membrane, 15 mm x 20 mm
Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery Terminated |
NPL | K003339 K011695 |
| Jan 27, 2017 | Biom'up RENOVIX Guided Healing Collagen Membrane
Intended for use in oral surgical procedures. Terminated |
NPL | K103087 |
| May 17, 2012 | Kensey Nash Corp a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2 Terminated |
NPL | K090919 |
| May 17, 2012 | Kensey Nash Corp a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2 Terminated |
NPL | K090919 |
| May 17, 2012 | Kensey Nash Corp a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2 Terminated |
NPL | K090919 |
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