# Dimensional Bioceramics, LLC

- Location (FDA's records): Santa Cruz, CA
- FDA decisions: 5 (2017–2021): 5 510(k) clearances
- Product codes: MQV (4), GXP (1)
- 510(k) review time since 2016: median 52 days, against 106 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Skeletal Kinetics, LLC: 4 (https://510kreport.com/company/skeletal-kinetics)
- Biocomposites, Ltd.: 1 (https://510kreport.com/company/biocomposites)

## Recent decisions
- K212353: DB-EZ Bone Void Filler (Sep 22, 2021)
- K210193: DB-Composite (Mar 15, 2021)
- K200752: DB-Orthopedics (Apr 22, 2020)
- K182742: DB-CMF (Jun 20, 2019)
- K171161: Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) (Sep 25, 2017)

Source page: https://510kreport.com/company/dimensional-bioceramics