The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultradent Prod Retract Cord/accessory Product Line.
| Device ID | K921601 |
| 510k Number | K921601 |
| Device Name: | ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE |
| Classification | Floss, Dental |
| 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 | JES |
| CFR Regulation Number | 872.6390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-03 |
| Decision Date | 1992-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540172009966 | K921601 | 000 |
| 07540172009959 | K921601 | 000 |
| 07540172009942 | K921601 | 000 |
| 07540172009935 | K921601 | 000 |
| 07540172009928 | K921601 | 000 |
| 07540172009911 | K921601 | 000 |