Triumph Resin Dam
510(k) K151945
Triumph Resin Dam is a medical device (FDA Class I; FDA product code EIE, Dam, Rubber) made by Denali Corporation, cleared under FDA 510(k) K151945 on 18 Feb 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151945 | Date18 Feb 2016 | StatusActive |
Official records
- FDA 510(k) database K151945
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EIE
- Device class
- Class I
- Regulation
- 21 CFR Part 872.6300
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K151945
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Liquid Magic - Resin Barrier 1.5 mL Syr - Evaluator | 47-5000 / 1.5 mL Syr - Evaluator | D8374750000 | Total Volume 1.5 mL | On the market |
| Liquid Magic - Resin Barrier Kit - 3 mL Syr - 2 pk | 47-1000 / Kit - 3 mL Syr - 2 pk | D8374710000 | Total Volume 3 mL | On the market |
Similar devices
Other devices filed under FDA product code EIE (Dam, Rubber).
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- WEDJETS by The Hygenic Company, LLC
- POWER BLOCK by Kreativ, Inc.
- DENTAL DAM SILICONE by Worldwide Dental, Inc.
- GC TION GINGIVAL PROTECTOR by Gc America Inc.
- KITCHIN DENTAL ABCESS DRAIN by Kitchin, Inc.
- DENT-DR. VACU-FRAME by Dent-Dr.
- DENTI-D RUBBER DAM by Fema Corp.