510(k) K062506
K062506 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "INCORIS AL". The FDA issued a decision of Substantially Equivalent on Sep 8, 2006. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Sirona Dental Systems GmbH has 41 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 8, 2006
- Date Received
- Aug 28, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type
- 510(k)