The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Valo, Model 5919.
| Device ID | K083647 |
| 510k Number | K083647 |
| Device Name: | VALO, MODEL 5919 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Diane Rogers |
| Correspondent | Diane Rogers 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 | 2008-12-09 |
| Decision Date | 2009-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205104915 | K083647 | 000 |
| 00883205029362 | K083647 | 000 |
| 00883205020314 | K083647 | 000 |
| 00883205019608 | K083647 | 000 |
| 00883205015518 | K083647 | 000 |
| 00883205015501 | K083647 | 000 |
| 00883205015495 | K083647 | 000 |
| 00883205004802 | K083647 | 000 |
| 00883205004574 | K083647 | 000 |
| 00883205029379 | K083647 | 000 |
| 00883205029386 | K083647 | 000 |
| 00883205104908 | K083647 | 000 |
| 00883205104892 | K083647 | 000 |
| 00883205104885 | K083647 | 000 |
| 00883205104878 | K083647 | 000 |
| 00883205104861 | K083647 | 000 |
| 00883205102997 | K083647 | 000 |
| 00883205101525 | K083647 | 000 |
| 00883205029393 | K083647 | 000 |
| 00883205000026 | K083647 | 000 |