NU-GLAZE
FDA 510(k) clearance K781935 · decided 1978-12-20
Clearance details
- K-number
- K781935
- Device name
- NU-GLAZE
- Applicant
- Deringer-Ney, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-11-20
- Decision date
- 1978-12-20
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- ELL
- Device class
- 2
- Regulation number
- 872.3920
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.