PERMAFLEX PERMANENT SOFT DENTURE RELINER
FDA 510(k) clearance K925062 · decided 1993-03-31
Clearance details
- K-number
- K925062
- Device name
- PERMAFLEX PERMANENT SOFT DENTURE RELINER
- Applicant
- Protech Professional Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-06
- Decision date
- 1993-03-31
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Centereach, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.