The following data is part of a premarket notification filed by Buffalo Dental Mfg. Co., Inc. with the FDA for Ultra-wet.
| Device ID | K820216 |
| 510k Number | K820216 |
| Device Name: | ULTRA-WET |
| Classification | Material, Impression |
| Applicant | BUFFALO DENTAL MFG. CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-26 |
| Decision Date | 1982-02-24 |