The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Valo Grand Corded.
| Device ID | K190627 |
| 510k Number | K190627 |
| Device Name: | VALO Grand Corded |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 |
| Contact | Karen Kakunes |
| Correspondent | Karen Kakunes Ultradent Products, Inc. 505 West Ultradent Drive (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 | 2019-03-12 |
| Decision Date | 2019-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205110275 | K190627 | 000 |
| 00883205041890 | K190627 | 000 |