The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Gi Dentstat.
| Device ID | K060334 |
| 510k Number | K060334 |
| Device Name: | GI DENTSTAT |
| Classification | Cement, Dental |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Tammy Lavery |
| Correspondent | Tammy Lavery ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-02-09 |
| Decision Date | 2006-02-23 |