OPALDAM
Retractor, All Types
ULTRADENT PRODUCTS, INC.
The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Opaldam.
Pre-market Notification Details
| Device ID | K971284 |
| 510k Number | K971284 |
| Device Name: | OPALDAM |
| Classification | Retractor, All Types |
| 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 | EIG |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-07 |
| Decision Date | 1997-06-03 |
Trademark Results [OPALDAM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPALDAM 75431581 2228430 Live/Registered |
Ultradent Products, Inc. 1998-02-11 |
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