The following data is part of a premarket notification filed by Block Drug Company, Inc. with the FDA for Sensodyne Sealant Dentin Conditioning System.
| Device ID | K884533 |
| 510k Number | K884533 |
| Device Name: | SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM |
| Classification | Agent, Tooth Bonding, Resin |
| 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-28 |
| Decision Date | 1989-04-12 |