The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultradent Universal Dentin Sealant.
| Device ID | K963979 |
| 510k Number | K963979 |
| Device Name: | ULTRADENT UNIVERSAL DENTIN SEALANT |
| Classification | Varnish, Cavity |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Dan E Fischer |
| Correspondent | Dan E Fischer ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-03 |
| Decision Date | 1996-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205104014 | K963979 | 000 |
| 00883205103338 | K963979 | 000 |
| 00883205103321 | K963979 | 000 |