Dimensional Bioceramics, LLC
Scotts Valley, CA, US
DIMENSIONAL BIOCERAMICS, LLC appears in FDA device records in Scotts Valley, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Dimensional Bioceramics, LLC between 2017 and 2021. The busiest year on record is 2021, with 2. The most recent is 2021, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212353 | DB-EZ Bone Void Filler | MQV | Substantially Equivalent | |
| K210193 | DB-Composite | MQV | Substantially Equivalent | |
| K200752 | DB-Orthopedics | MQV | Substantially Equivalent | |
| K182742 | DB-CMF | GXP | Substantially Equivalent | |
| K171161 | Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) | MQV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016592693 | 3016592693 | DIMENSIONAL BIOCERAMICS, LLC | 300 El Pueblo Rd Ste 100, Scotts Valley, CA 95066 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain