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 |