1ST IMPRESSION
FDA 510(k) clearance K983106 · decided 1999-02-09
Clearance details
- K-number
- K983106
- Device name
- 1ST IMPRESSION
- Applicant
- Den-Mat Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-04
- Decision date
- 1999-02-09
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- 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.