The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultradent Product Pit & Fissure Sealant Prod Line.
| Device ID | K921598 |
| 510k Number | K921598 |
| Device Name: | ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ULTRADENT PRODUCTS, INC. 1345 E. 3900 SO. Salt Lake City, UT 84124 |
| Contact | Linda Chatwin |
| Correspondent | Linda Chatwin ULTRADENT PRODUCTS, INC. 1345 E. 3900 SO. Salt Lake City, UT 84124 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-03 |
| Decision Date | 1992-09-09 |