The following data is part of a premarket notification filed by Mycone Dental Supply Company, Inc. (aka Keystone Industries) with the FDA for Keymill.
Device ID | K172764 |
510k Number | K172764 |
Device Name: | Keymill |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | Mycone Dental Supply Company, Inc. (aka Keystone Industries) 480 S Democrat Road Gibbstown, NJ 08027 |
Contact | Priscilla Herpai |
Correspondent | Priscilla Herpai Mycone Dental Supply Company, Inc. (aka Keystone Industries) 480 S Democrat Road Gibbstown, NJ 08027 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-13 |
Decision Date | 2018-04-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H66810093131 | K172764 | 000 |
H66810093121 | K172764 | 000 |
H66810093111 | K172764 | 000 |
H66810093101 | K172764 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KEYMILL 87873364 not registered Live/Pending |
Mycone Dental Supply Co., Inc. 2018-04-11 |
KEYMILL 76383172 2758178 Dead/Cancelled |
KUBOTEK CORPORATION 2002-03-15 |