ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER
FDA 510(k) clearance K934248 · decided 1993-12-08
Clearance details
- K-number
- K934248
- Device name
- ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER
- Applicant
- Wallace A. Erickson & Co.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-30
- Decision date
- 1993-12-08
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.