510(k) K895522
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1989
- Date Received
- September 12, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adhesive, Bracket And Tooth Conditioner, Resin
- Device Class
- Class II
- Regulation Number
- 872.3750
- Review Panel
- DE
- Submission Type