The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Dynamatrix/dynamatrix Plus.
| Device ID | K161762 |
| 510k Number | K161762 |
| Device Name: | DynaMatrix/Dynamatrix Plus |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Contact | Perry W. Guinn |
| Correspondent | Perry W. Guinn COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-27 |
| Decision Date | 2017-01-13 |
| Summary: | summary |