The following data is part of a premarket notification filed by Matricel Gmbh with the FDA for Matricel Dental Barrier Membrane.
| Device ID | K123697 |
| 510k Number | K123697 |
| Device Name: | MATRICEL DENTAL BARRIER MEMBRANE |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | MATRICEL GMBH KAISERSTRABE 100 Herzogenrath, DE 52134 |
| Contact | Dr. Ingo Heschel |
| Correspondent | Dr. Ingo Heschel MATRICEL GMBH KAISERSTRABE 100 Herzogenrath, DE 52134 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-03 |
| Decision Date | 2014-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250830900643 | K123697 | 000 |
| 04250830900636 | K123697 | 000 |
| 04250830900629 | K123697 | 000 |
| 04250830900827 | K123697 | 000 |
| 04250830900810 | K123697 | 000 |
| 04250830900803 | K123697 | 000 |