The following data is part of a premarket notification filed by Block Drug Company, Inc. with the FDA for Proficient(tm) Prophylaxis Angle.
Device ID | K881974 |
510k Number | K881974 |
Device Name: | PROFICIENT(TM) PROPHYLAXIS ANGLE |
Classification | Handpiece, Air-powered, Dental |
Applicant | BLOCK DRUG COMPANY, INC. 257 CORNELISON AVE. Jersey City, NJ 07302 |
Contact | Howard Feinman |
Correspondent | Howard Feinman BLOCK DRUG COMPANY, INC. 257 CORNELISON AVE. Jersey City, NJ 07302 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-11 |
Decision Date | 1988-07-25 |