510(k) K121804
K121804 is an FDA 510(k) premarket notification submitted by Itena Clinical for the device "PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM". The FDA issued a decision of Substantially Equivalent on April 19, 2013. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Itena Clinical has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 2013
- Date Received
- June 19, 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