PROCLUDE
Agent, Polishing, Abrasive, Oral Cavity
ORTEK THERAPEUTICS, INC.
The following data is part of a premarket notification filed by Ortek Therapeutics, Inc. with the FDA for Proclude.
Pre-market Notification Details
| Device ID | K002989 |
| 510k Number | K002989 |
| Device Name: | PROCLUDE |
| Classification | Agent, Polishing, Abrasive, Oral 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 | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-25 |
| Decision Date | 2000-12-14 |
Trademark Results [PROCLUDE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROCLUDE 76194159 2632982 Dead/Cancelled |
COLGATE-PALMOLIVE COMPANY 2001-01-15 |
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