The following data is part of a premarket notification filed by Liaoning Upcera Co.,ltd with the FDA for Dental Lithium Disilicate Glass Ceramic Block (up. Press Series And Up. Cad Series).
Device ID | K141727 |
510k Number | K141727 |
Device Name: | DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) |
Classification | Powder, Porcelain |
Applicant | LIAONING UPCERA CO.,LTD 853 DORCHESTER LN, SUITE-B New Milford, NJ 07646 |
Contact | Charles Shen |
Correspondent | Charles Shen LIAONING UPCERA CO.,LTD 853 DORCHESTER LN, SUITE-B New Milford, NJ 07646 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-26 |
Decision Date | 2014-12-18 |
Summary: | summary |