Glidewell™ Denture Base Resin
by Prismatik Dentalcraft, Inc.
510(k) K261802
Glidewell™ Denture Base Resin is a Class II device made by Prismatik Dentalcraft, Inc., cleared under FDA 510(k) K261802 on 27 Aug 2026, active as of 25 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 | NumberK261802 | Date27 Aug 2026 | StatusActive |
Official records
- FDA 510(k) database K261802
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBI
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K261802
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 | |||
|---|---|---|---|---|
| Glidewell™ Denture Base Resin 70-1164-HDB0001 | 70-1164-HDB0001 / 70-1164-HDB0001 | D745701164HDB00010 | — | On the market |
| Glidewell™ Denture Base Resin 70-1164-HDB0002 | 70-1164-HDB0002 / 70-1164-HDB0002 | D745701164HDB00020 | — | On the market |
| Glidewell™ Denture Base Resin 70-1164-HDB0003 | 70-1164-HDB0003 / 70-1164-HDB0003 | D745701164HDB00030 | — | On the market |
Similar devices
Other devices filed under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing).
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- ORTHODONTIC ACRYLIC (NOT FINALIZED) by BISCO INC.
- everStick® 900822 by Gc America Inc.
- AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL by Austenal Dental, Inc.