The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Deox, Oxygen Barrier Viscous Solution.
| Device ID | K941065 |
| 510k Number | K941065 |
| Device Name: | DEOX, OXYGEN BARRIER VISCOUS SOLUTION |
| Classification | Cement, Dental |
| Applicant | ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
| Contact | Linda Chatwin |
| Correspondent | Linda Chatwin ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-08 |
| Decision Date | 1994-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205103376 | K941065 | 000 |
| 00883205031884 | K941065 | 000 |