The following data is part of a premarket notification filed by Ultradent Products, Inc with the FDA for Valo Grand Corded And Accessory Lenses.
| Device ID | K210550 |
| 510k Number | K210550 |
| Device Name: | VALO Grand Corded And 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 | 2021-02-25 |
| Decision Date | 2021-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205104908 | K210550 | 000 |
| 00883205031808 | K210550 | 000 |
| 00883205031815 | K210550 | 000 |
| 00883205101655 | K210550 | 000 |
| 00883205101662 | K210550 | 000 |
| 00883205101686 | K210550 | 000 |
| 00883205101723 | K210550 | 000 |
| 00883205004802 | K210550 | 000 |
| 00883205015495 | K210550 | 000 |
| 00883205102997 | K210550 | 000 |
| 00883205031792 | K210550 | 000 |