The following data is part of a premarket notification filed by Talladium, Inc. with the FDA for Luminesse Anterior Zirconia At.
Device ID | K152066 |
510k Number | K152066 |
Device Name: | Luminesse Anterior Zirconia AT |
Classification | Powder, Porcelain |
Applicant | TALLADIUM, INC. 27360 WEST MUIRFIELD LANE Valencia, CA 91355 |
Contact | Edward Harms |
Correspondent | Edward Harms TALLADIUM, INC. 27360 WEST MUIRFIELD LANE Valencia, CA 91355 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-24 |
Decision Date | 2015-10-21 |
Summary: | summary |