The following data is part of a premarket notification filed by Ortek Therapeutics, Inc. with the FDA for Proclude-sensitive.
| Device ID | K003482 |
| 510k Number | K003482 |
| Device Name: | PROCLUDE-SENSITIVE |
| Classification | Varnish, Cavity |
| Applicant | ORTEK THERAPEUTICS, INC. 305 MADISON AVE. SUITE 2501 New York, NY 10165 |
| Contact | Jules T Mitchel |
| Correspondent | Jules T Mitchel ORTEK THERAPEUTICS, INC. 305 MADISON AVE. SUITE 2501 New York, NY 10165 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-09 |
| Decision Date | 2001-02-01 |