The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Valo Cordless.
| Device ID | K110582 |
| 510k Number | K110582 |
| Device Name: | VALO CORDLESS |
| 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 | 2011-03-01 |
| Decision Date | 2011-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205105097 | K110582 | 000 |
| 00883205104847 | K110582 | 000 |
| 00883205104854 | K110582 | 000 |
| 00883205104939 | K110582 | 000 |
| 00883205104946 | K110582 | 000 |
| 00883205104960 | K110582 | 000 |
| 00883205104984 | K110582 | 000 |
| 00883205105004 | K110582 | 000 |
| 00883205105011 | K110582 | 000 |
| 00883205105035 | K110582 | 000 |
| 00883205105042 | K110582 | 000 |
| 00883205105066 | K110582 | 000 |
| 00883205105073 | K110582 | 000 |
| 00883205105080 | K110582 | 000 |
| 00883205104809 | K110582 | 000 |