510(k) K121769
K121769 is an FDA 510(k) premarket notification submitted by Itena Clinical for the device "DENTOCORE / DENTOCORE BODY". The FDA issued a decision of Substantially Equivalent on March 5, 2013. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Itena Clinical has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2013
- Date Received
- June 15, 2012
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type