VALO Grand
Activator, Ultraviolet, For Polymerization
ULTRADENT PRODUCTS, INC.
The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Valo Grand.
Pre-market Notification Details
| Device ID | K160551 |
| 510k Number | K160551 |
| Device Name: | VALO Grand |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Marie Hess |
| Correspondent | Corey Jaseph ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-07-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205105103 | K160551 | 000 |
| 00883205019226 | K160551 | 000 |
| 00883205019219 | K160551 | 000 |
Trademark Results [VALO Grand]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VALO GRAND 88633590 not registered Live/Pending |
Ultradent Products, Inc. 2019-09-27 |
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