The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Chromaclone Color Changing Alginate Impress Materials.
| Device ID | K940860 |
| 510k Number | K940860 |
| Device Name: | CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS |
| Classification | Material, Impression |
| Applicant | ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
| Contact | F.m. Havenga |
| Correspondent | F.m. Havenga ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-23 |
| Decision Date | 1994-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205107749 | K940860 | 000 |
| 00883205033062 | K940860 | 000 |