510(k) K161042
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack by
Kuraray Noritake Dental, Inc.
— Product Code KLE
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2016
- Date Received
- April 13, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agent, Tooth Bonding, Resin
- Device Class
- Class II
- Regulation Number
- 872.3200
- Review Panel
- DE
- Submission Type