The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Zirprime.
Device ID | K121980 |
510k Number | K121980 |
Device Name: | ZIRPRIME |
Classification | Powder, Porcelain |
Applicant | KURARAY NORITAKE DENTAL INC. 700 12TH ST SW SUITE 100 Washington, DC 20005 |
Contact | Ivan Wasserman |
Correspondent | Ivan Wasserman KURARAY NORITAKE DENTAL INC. 700 12TH ST SW SUITE 100 Washington, DC 20005 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-07-06 |
Decision Date | 2012-10-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZIRPRIME 77861534 4230336 Dead/Cancelled |
Noritake Co., Limited 2009-10-30 |