Fit Checker Advanced
510(k) K110871
Fit Checker Advanced is a Class II device made by Gc America Inc., cleared under FDA 510(k) K110871 on 17 Jun 2011, 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 | NumberK110871 | Date17 Jun 2011 | StatusActive |
Official records
- FDA 510(k) database K110871
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELW
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K110871
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 | |||
|---|---|---|---|---|
| FIT CHECKER™ 004903 | 004903 / 004903 | 14548161282437 | — | On the market |
| FIT CHECKER™ 004903 | 004903 / 004903 | D0470049031 | — | On the market |
| FIT CHECKER™ 004904 | 004904 / 004904 | 14548161297257 | Total Volume 48 mL | On the market |
| FIT CHECKER™ 004904 | 004904 / 004904 | D0470049041 | Total Volume 48 mL | On the market |
Similar devices
Other devices filed under FDA product code ELW (Material, Impression).
- KROMALGIN IMPRESSION MATERIAL by North American Orthodontic Laboratories, Inc.
- RAMITEC PENTA by Espe GmbH & Co. Kg.
- CEREC Optispray 6144179 by SIRONA Dental Systems GmbH
- IOS FASTSCAN SPRAY by Ios Technnologies, Inc.
- GENESIS by Pacific Rim Dental, Inc.
- Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) by PREVEST DENPRO LIMITED
- Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite by Hrs Co., Ltd.
- FIRST IMPRESSION WITH CHLORHEXIDINE by Coe Laboratories, Inc.
- AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL by Dentsply International
- TULIP ALGINATE IMPRESSION MATERIAL by Cavex Holland BV