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ADX6000 +1 more model

FDA UDI

Class II (US FDA UDI)

by Dexcowin Co., Ltd.

Identity

Trade Name
ADX6000; iRay A6 FDA UDI
Generic Name
Hand-held intraoral dental x-ray system, digital FDA UDI
Device Name
Portable x-ray system intended for dental radio-graphic examination and diagnosis of diseases of the teeth, jaw and oral structure for both pediatric and adult patients. FDA UDI
Model / Reference
ADX6000 FDA UDI
Description
Portable x-ray system intended for dental radio-graphic examination and diagnosis of diseases of the teeth, jaw and oral structure for both pediatric and adult patients. FDA UDI

Identifiers

Primary DI / UDI-DI
08800000500027 FDA UDI
FDA Product Code
MUH FDA UDI
GMDN Term
Hand-held intraoral dental x-ray system, digital FDA UDI
Models / Variants
ADX6000 FDA UDI
iRay A6 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: Hand-held intraoral dental x-ray system, digital

ADX6000 +1 more model by Dexcowin Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dexcowin Co., Ltd.

Sources (1)

  • FDA UDI 7a64607e-875d-41ae-a540-6a0cf8378200 35 fields · synced May 30, 2026