The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Viscostat Clear.
| Device ID | K123215 |
| 510k Number | K123215 |
| Device Name: | VISCOSTAT CLEAR |
| Classification | Cord, Retraction |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Karen Kakunes |
| Correspondent | Karen Kakunes ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-15 |
| Decision Date | 2013-02-05 |
| Summary: | summary |