DIMENSION PENTA H, DIMENSION PENTA H QUICK
FDA 510(k) clearance K000591 · decided 2000-03-30
Clearance details
- K-number
- K000591
- Device name
- DIMENSION PENTA H, DIMENSION PENTA H QUICK
- Applicant
- Espe Dental AG
- Decision
- Substantially Equivalent
- Date received
- 2000-02-22
- Decision date
- 2000-03-30
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Bavaria D-82228 Seefeld, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Cata recall (Z-0535-2014) | 3M Company - Health Care Business | 2013-12-18 |