The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultracal Xs.
| Device ID | K211905 |
| 510k Number | K211905 |
| Device Name: | UltraCal XS |
| Classification | Resin, Root Canal Filling |
| Applicant | Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 |
| Contact | Adam Black |
| Correspondent | Adam Black Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2021-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205033260 | K211905 | 000 |
| 00883205033253 | K211905 | 000 |
| 00883205033246 | K211905 | 000 |