510(k) K894477
K894477 is an FDA 510(k) premarket notification submitted by Cosmedent, Inc. for the device "INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 10, 1990. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Cosmedent, Inc. has 27 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 10, 1990
- Date Received
- Jul 18, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type
- 510(k)