DERMADAM
Unit, Oral Irrigation
ULTRADENT PRODUCTS, INC.
The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Dermadam.
Pre-market Notification Details
| Device ID | K964810 |
| 510k Number | K964810 |
| Device Name: | DERMADAM |
| Classification | Unit, Oral Irrigation |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-02-10 |
Trademark Results [DERMADAM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DERMADAM 75177462 2226555 Live/Registered |
Ultradent Products, Inc. 1996-10-07 |
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