510(k) K982164
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1998
- Date Received
- June 19, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type