510(k) K141727
K141727 is an FDA 510(k) premarket notification submitted by Liaoning Upcera Co., Ltd. for the device "DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES)". The FDA issued a decision of Substantially Equivalent on December 18, 2014. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Liaoning Upcera Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2014
- Date Received
- June 26, 2014
- Clearance Type
- Traditional
- 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