510(k) K994172
K994172 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "CEREC 3". The FDA issued a decision of Substantially Equivalent on Feb 8, 2000. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Sirona Dental Systems GmbH has 41 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 8, 2000
- Date Received
- Dec 10, 1999
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type
- 510(k)