The following data is part of a premarket notification filed by Continental Dental Ceramics, Inc. (dba Continental with the FDA for Cdc Zirconia Blanks.
Device ID | K122972 |
510k Number | K122972 |
Device Name: | CDC ZIRCONIA BLANKS |
Classification | Powder, Porcelain |
Applicant | CONTINENTAL DENTAL CERAMICS, INC. (DBA CONTINENTAL 1873 WESTERN WAY Torrance, CA 90501 |
Contact | Jerry Doviack, Cdt |
Correspondent | Jerry Doviack, Cdt CONTINENTAL DENTAL CERAMICS, INC. (DBA CONTINENTAL 1873 WESTERN WAY Torrance, CA 90501 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-26 |
Decision Date | 2012-10-24 |
Summary: | summary |