510(k) K120283
K120283 is an FDA 510(k) premarket notification submitted by Novocol, Inc. for the device "DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT". The FDA issued a decision of Substantially Equivalent on July 31, 2012. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Novocol, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2012
- Date Received
- January 31, 2012
- Clearance Type
- Abbreviated
- 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