The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultracal Xs.
| Device ID | K970114 |
| 510k Number | K970114 |
| Device Name: | ULTRACAL XS |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-13 |
| Decision Date | 1997-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205103987 | K970114 | 000 |
| 00883205103970 | K970114 | 000 |
| 00883205103741 | K970114 | 000 |
| 00883205102515 | K970114 | 000 |