The following data is part of a premarket notification filed by Dimensional Bioceramics, Llc. with the FDA for Db-ez Bone Void Filler.
| Device ID | K212353 |
| 510k Number | K212353 |
| Device Name: | DB-EZ Bone Void Filler |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Dimensional Bioceramics, LLC. 2161 Delaware Avenue, Suite A Santa Cruz, CA 95060 |
| Contact | Duran N. Yetkinliner |
| Correspondent | Patsy J. Trisler Trisler Consulting 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-29 |
| Decision Date | 2021-09-22 |