← Back to catalogue

Belray Ii

FDA UDI

Class II (US FDA UDI)

by Takara Belmont Corp.

Identity

Trade Name
BELRAY II FDA UDI
Generic Name
Stationary intraoral dental x-ray system, analogue FDA UDI
Device Name
097 X-RAY WK with 12"Arm FDA UDI
Model / Reference
097 FDA UDI
Description
097 X-RAY WK with 12"Arm FDA UDI

Identifiers

Catalog Number
AR-97WKCNJ3 FDA UDI
Primary DI / UDI-DI
04952195093922 FDA UDI
510(k) Number
K093240 FDA UDI
FDA Product Code
MUH FDA UDI
EHD FDA UDI
GMDN Term
Stationary intraoral dental x-ray system, analogue 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

Yes

FDA UDI

Category: Stationary intraoral dental x-ray system, analogue

Belray Ii by Takara Belmont Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K093240 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Takara Belmont Corp.

Sources (1)

  • FDA UDI 5e9f7805-b617-412f-b346-bb588414dbbe 37 fields · synced May 31, 2026