510(k) K052501
K052501 is an FDA 510(k) premarket notification submitted by Cosmedent, Inc. for the device "MULTIPLE RESIN TOOTH BONDING AGENT". The FDA issued a decision of Substantially Equivalent on Oct 21, 2005. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Cosmedent, Inc. has 27 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 21, 2005
- Date Received
- Sep 13, 2005
- 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
- 510(k)