Duray XR2011
by Beyes Dental Canada Inc 2 variants
Duray XR2011 is a Class II device made by Beyes Dental Canada Inc, cleared under FDA 510(k) K031118 on 8 Jul 2003 and listed in FDA GUDID since 5 Oct 2022 (UDI-DI 00837699000116), active as of 23 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 | Number00837699000116 | Date5 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031118 | Date8 Jul 2003 | StatusActive |
Official records
- AccessGUDID record 00837699000116
- FDA 510(k) database K031118
Across registries
- FDA 510(k) K031118 decided 8 Jul 2003 Active
- FDA GUDID UDI-DI 00837699000116 listed 5 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K031118
- Listed FDA GUDID 00837699000116
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Duray
- Generic name
- Stationary intraoral dental x-ray system, digital
- Model / reference
- XR2011
- Description
- DURAY V2, DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length
- Primary DI / UDI-DI
- 00837699000116
- 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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