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Duray

FDA UDI

Class II (US FDA UDI)

by Beyes Dental Canada Inc

Identity

Trade Name
DURAY FDA UDI
Generic Name
Stationary intraoral dental x-ray system, digital FDA UDI
Device Name
DURAY V2, DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length FDA UDI
Model / Reference
XR2011 FDA UDI
Description
DURAY V2, DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length FDA UDI

Identifiers

Primary DI / UDI-DI
00837699000116 FDA UDI
510(k) Number
K031118 FDA UDI
FDA Product Code
EHD FDA UDI
GMDN Term
Stationary intraoral dental x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Stationary intraoral dental x-ray system, digital

Duray by Beyes Dental Canada Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary intraoral dental x-ray system, digital.

Cleared under the same submission

K031118 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beyes Dental Canada Inc

Sources (1)

  • FDA UDI 14f61990-cdf0-45d6-ac64-ea75cf0cc0df 34 fields · synced Jun 1, 2026