510(k) K070019
K070019 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "CARRARA VOLUMIA". The FDA issued a decision of Substantially Equivalent on January 26, 2007. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Dentsply Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 2007
- Date Received
- January 3, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type