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 |