DEN-MAT PORETCH (PORCELAIN ETCHANT)
FDA 510(k) clearance K875351 · decided 1988-03-18
Clearance details
- K-number
- K875351
- Device name
- DEN-MAT PORETCH (PORCELAIN ETCHANT)
- Applicant
- Den-Mat Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-31
- Decision date
- 1988-03-18
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- ELL
- Device class
- 2
- Regulation number
- 872.3920
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Santa Maria, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.