ELITE GLASS
Material, Impression
ZHERMACK S.P.A.
The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Elite Glass.
Pre-market Notification Details
| Device ID | K073005 |
| 510k Number | K073005 |
| Device Name: | ELITE GLASS |
| Classification | Material, Impression |
| Applicant | ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Contact | Gerald W Shipps |
| Correspondent | Gerald W Shipps ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-24 |
| Decision Date | 2007-12-12 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00359883001841 | K073005 | 000 |
| 00359883001476 | K073005 | 000 |
| 00359883001452 | K073005 | 000 |
Trademark Results [ELITE GLASS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELITE GLASS 88496692 not registered Live/Pending |
Elite Glass, LLC 2019-07-01 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.