The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultrapak E.
| Device ID | K981596 |
| 510k Number | K981596 |
| Device Name: | ULTRAPAK E |
| Classification | Cord, Retraction |
| Applicant | ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
| 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 | 1998-05-04 |
| Decision Date | 1998-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6620708903270 | K981596 | 000 |
| D6620708903190 | K981596 | 000 |
| D6620708903010 | K981596 | 000 |
| D6620708902930 | K981596 | 000 |