LUXAGLAZE
FDA 510(k) clearance K013179 · decided 2001-10-12
Clearance details
- K-number
- K013179
- Device name
- LUXAGLAZE
- Applicant
- Dmg USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-24
- Decision date
- 2001-10-12
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- EBD
- Device class
- 2
- Regulation number
- 872.3310
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Dover, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.