The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Zylox.
| Device ID | K782139 |
| 510k Number | K782139 |
| Device Name: | ZYLOX |
| Classification | Material, Impression |
| Applicant | PREMIER DENTAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-27 |
| Decision Date | 1979-02-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZYLOX 98713947 not registered Live/Pending |
Xu Fan 2024-08-23 |
![]() ZYLOX 98630022 not registered Live/Pending |
Cai, Meiqin 2024-07-02 |
![]() ZYLOX 73238475 1160585 Dead/Cancelled |
Premier Dental Products Company 1979-11-08 |
![]() ZYLOX 72263384 0849271 Dead/Expired |
KYANIZE PAINTS, INC. 1967-01-26 |