510(k) K043562
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2005
- Date Received
- December 27, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Agent, Tooth Bonding, Resin
- Device Class
- Class II
- Regulation Number
- 872.3200
- Review Panel
- DE
- Submission Type