The following data is part of a premarket notification filed by Essential Dental Systems, Inc. with the FDA for Ultra Hydrophilic Alginae.
| Device ID | K943475 |
| 510k Number | K943475 |
| Device Name: | ULTRA HYDROPHILIC ALGINAE |
| Classification | Material, Impression |
| Applicant | ESSENTIAL DENTAL SYSTEMS, INC. 89 LEUNING ST. South Hackensack, NJ 07606 |
| Contact | Anand Akerkar |
| Correspondent | Anand Akerkar ESSENTIAL DENTAL SYSTEMS, INC. 89 LEUNING ST. South Hackensack, NJ 07606 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1994-08-12 |