510(k) K974494
K974494 is an FDA 510(k) premarket notification submitted by Cosmedent, Inc. for the device "RENAMEL FLOWABLE COMPOSITE". The FDA issued a decision of Substantially Equivalent on Feb 10, 1998. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. Cosmedent, Inc. has 27 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 10, 1998
- Date Received
- Nov 28, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Coating, Filling Material, Resin
- Device Class
- Class II
- Regulation Number
- 872.3310
- Review Panel
- DE
- Submission Type
- 510(k)