The following data is part of a premarket notification filed by Block Drug Company, Inc. with the FDA for Vision Prophy Paste With Fluoride.
| Device ID | K935925 |
| 510k Number | K935925 |
| Device Name: | VISION PROPHY PASTE WITH FLUORIDE |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | BLOCK DRUG COMPANY, INC. 257 CORNELISON AVE. Jersey City, NJ 07302 |
| Contact | Orville W Ostmann |
| Correspondent | Orville W Ostmann BLOCK DRUG COMPANY, INC. 257 CORNELISON AVE. Jersey City, NJ 07302 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-01-26 |