Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dimensional Bioceramics, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
265 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212353 | DB-EZ Bone Void Filler | Dimensional Bioceramics, LLC | 2021-09-22 | 55 | 0 |
| K210193 | DB-Composite | Dimensional Bioceramics, LLC | 2021-03-15 | 49 | 0 |
| K200752 | DB-Orthopedics | Dimensional Bioceramics, LLC | 2020-04-22 | 30 | 0 |
| K182742 | DB-CMF | Dimensional Bioceramics, LLC | 2019-06-20 | 265 | 0 |
| K171161 | Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) | Dimensional Bioceramics, LLC | 2017-09-25 | 158 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda