The following data is part of a premarket notification filed by Dimensional Bioceramics, Llc with the FDA for Db-cmf.
| Device ID | K182742 |
| 510k Number | K182742 |
| Device Name: | DB-CMF |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | Dimensional Bioceramics, LLC 250 Natural Bridges Drive Santa Cruz, CA 95050 |
| Contact | Duran N. Yetkinler |
| Correspondent | Patsy J. Trisler Trisler Consulting 5600 Wisconsin Ave, #509 Chevy Chase, MD 20815 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850018568104 | K182742 | 000 |
| 00850018568173 | K182742 | 000 |
| 00850018568166 | K182742 | 000 |
| 00850018568159 | K182742 | 000 |
| 00850018568142 | K182742 | 000 |
| 00850018568135 | K182742 | 000 |
| 00850018568128 | K182742 | 000 |
| 00850018568111 | K182742 | 000 |