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Owandy-RX PRO

FDA UDI

Class II (US FDA UDI)

by Owandy Radiology

Identity

Trade Name
Owandy-RX PRO FDA UDI
Generic Name
Stationary intraoral dental x-ray system, digital FDA UDI
Device Name
Owandy-RX PRO TOP 110 SHORT CONE, with interface wall plate (16") FDA UDI
Model / Reference
OWANDY-RX PRO TOP 110 SHORT CONE, INTERF WALL PLATE (16”) FDA UDI
Description
Owandy-RX PRO TOP 110 SHORT CONE, with interface wall plate (16") FDA UDI

Identifiers

Catalog Number
W0806002 FDA UDI
Primary DI / UDI-DI
03760262650654 FDA UDI
510(k) Number
K132378 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

Owandy-RX PRO by Owandy Radiology — 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

K132378 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Owandy Radiology

Sources (1)

  • FDA UDI cc856185-c9fd-4157-ba23-5c8f28b2e824 36 fields · synced May 30, 2026