The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Valo X, Valo X Accessory Lenses.
| Device ID | K220471 |
| 510k Number | K220471 |
| Device Name: | VALO X, VALO X Accessory Lenses |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 |
| Contact | Adam Black |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | EBZ |
| Subsequent Product Code | EAQ |
| Subsequent Product Code | PEQ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-02-18 |
| Decision Date | 2022-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205034489 | K220471 | 000 |
| 00883205034175 | K220471 | 000 |
| 00883205034182 | K220471 | 000 |
| 00883205034199 | K220471 | 000 |
| 00883205034205 | K220471 | 000 |
| 00883205039163 | K220471 | 000 |
| 00883205032881 | K220471 | 000 |
| 00883205032973 | K220471 | 000 |
| 00883205033154 | K220471 | 000 |
| 00883205034472 | K220471 | 000 |
| 00883205034168 | K220471 | 000 |