The following data is part of a premarket notification filed by Dimensional Bioceramics Llc with the FDA for Dimensional Bioceramics Calcium Sulfate Device (db-csd).
| Device ID | K171161 |
| 510k Number | K171161 |
| Device Name: | Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Dimensional Bioceramics LLC 163 McKenzie Creek Road Scotts Valley, CA 95066 |
| Contact | David Delaney |
| Correspondent | Patsy J. Trisler Trisler Consulting 5600 Wisconsin Avenue #509 Chevy Chase, MD 20815 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-20 |
| Decision Date | 2017-09-25 |
| Summary: | summary |