J-Temp
Material, Tooth Shade, Resin
Ultradent Products, Inc.
The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for J-temp.
Pre-market Notification Details
| Device ID | K221909 |
| 510k Number | K221909 |
| Device Name: | J-Temp |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Ultradent Products, Inc. 505 W Ultradent Drive (10200 South) South Jordan, UT 84095 |
| Contact | Matthew Buck |
| Correspondent | DAVE YUNGVIRT THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-06-30 |
| Decision Date | 2022-07-01 |
Trademark Results [J-Temp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 J-TEMP 90044417 not registered Live/Pending |
Ultradent Products, Inc. 2020-07-09 |
 J-TEMP 80985105 0985105 Dead/Cancelled |
Johnson & Johnson 0000-00-00 |
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