510(k) K083304
K083304 is an FDA 510(k) premarket notification submitted by Coltene/Whaledent AG for the device "TEMPOSIL 2". The FDA issued a decision of Substantially Equivalent on February 6, 2009. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Coltene/Whaledent AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2009
- Date Received
- November 10, 2008
- 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