The following data is part of a premarket notification filed by Sultan Chemists, Inc. with the FDA for Genie Ultra Hydrophilic Impression Material.
| Device ID | K030414 |
| 510k Number | K030414 |
| Device Name: | GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | SULTAN CHEMISTS, INC. 85 WEST FOREST AVE. Englewood, NJ 07631 |
| Contact | Clark Smith |
| Correspondent | Clark Smith SULTAN CHEMISTS, INC. 85 WEST FOREST AVE. Englewood, NJ 07631 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-07 |
| Decision Date | 2003-04-09 |