x-mind dc
x-mind dc (5.92.15101) is a Class II device made by De Götzen SRL, cleared under FDA 510(k) K231055 on 28 Dec 2023 and listed in FDA GUDID since 4 Sep 2025 (UDI-DI D804592151010), active as of 21 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD804592151010 | Date4 Sep 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231055 | Date28 Dec 2023 | StatusActive |
Official records
- FDA 510(k) database K231055
Across registries
- FDA 510(k) K231055 decided 28 Dec 2023 Active
- FDA GUDID UDI-DI D804592151010 listed 4 Sep 2025 Listed
Timeline
- Cleared FDA 510(k) K231055
- Listed FDA GUDID D804592151010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Stationary intraoral dental x-ray system, digital
- Model / Ref / Catalog
- DC X-MIND 115V, SHORT CONE, BOTT 80 (16” - 40, 64cm), 5.92.15101
- Primary DI / UDI-DI
- D804592151010
- 510(k) Number
- FDA product code
- EHD
- GMDN term
- Stationary intraoral dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
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