PERMALUTE
Agent, Tooth Bonding, Resin
ULTRADENT PRODUCTS, INC.
The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Permalute.
Pre-market Notification Details
| Device ID | K950860 |
| 510k Number | K950860 |
| Device Name: | PERMALUTE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | L. M Chatwin |
| Correspondent | L. M Chatwin ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-03-23 |
Trademark Results [PERMALUTE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERMALUTE 75248218 2132680 Dead/Cancelled |
Ultradent Products, Inc. 1997-02-26 |
 PERMALUTE 74556183 not registered Dead/Abandoned |
ULTRADENT PRODUCTS, INC. 1994-08-02 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.