CORRECTED-V.P.S.
FDA 510(k) clearance K914178 · decided 1992-04-28
Clearance details
- K-number
- K914178
- Device name
- CORRECTED-V.P.S.
- Applicant
- Jeneric/Pentron, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-18
- Decision date
- 1992-04-28
- Days to decision
- 223 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Wallingford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use recall (Z-1146-2012) | Sybron Dental Specialties | 2012-03-02 |