The following data is part of a premarket notification filed by Metalor Dental Usa Corp. with the FDA for Ceraplus.
Device ID | K911674 |
510k Number | K911674 |
Device Name: | CERAPLUS |
Classification | Alloy, Other Noble Metal |
Applicant | METALOR DENTAL USA CORP. 457 LAUREL RD. BOX 369 Rockville Centre, NY 11571 -0369 |
Contact | Brian Schiller |
Correspondent | Brian Schiller METALOR DENTAL USA CORP. 457 LAUREL RD. BOX 369 Rockville Centre, NY 11571 -0369 |
Product Code | EJS |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-11 |
Decision Date | 1991-08-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CERAPLUS 86419796 4834951 Live/Registered |
Hollister Incorporated 2014-10-09 |