Core*it Dual
510(k) K092572
Core*it Dual is a medical device (FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Spident Co., Ltd., cleared under FDA 510(k) K092572 on 26 Aug 2009, 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 | NumberK092572 | Date26 Aug 2009 | StatusActive |
Official records
- FDA 510(k) database K092572
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K092572
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 | |||
|---|---|---|---|---|
| Core It Blue 101-0302 | 101-0302 / 101-0302 | 08809262954845 | On the market | |
| Core It White 101-0303 | 101-0303 / 101-0303 | 08809262954869 | On the market | |
| Core It Yellow 101-0301 | 101-0301 / 101-0301 | 08809262954838 | On the market | |
| EsBond Activator 101-0502 | 101-0502 / 101-0502 | 08809262955439 | On the market | |
| Esbond S1 101-5006 | 101-5006 / 101-5006 | 08809262959949 | On the market | |
| EsBond S2 101-5007 | 101-5007 / 101-5007 | 08809262959956 | On the market |
Similar devices
Other devices filed under FDA product code EBF (Material, Tooth Shade, Resin).
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- MIRIS2 8408 by Coltène/Whaledent AG
- Admira 2424 by VOCO GmbH
- VERSAETCH by CENTRIX, INC.