Xdr

FDA UDI

Class II (US FDA UDI)

by Cyber Medical Imaging, Inc.

Identity

Trade Name: XDR FDA UDI
Generic Name: Dental digital imaging sensor, intraoral FDA UDI
Device Name: Dental digital intraoral sensor, size 2 FDA UDI
Model / Reference: Anatomic Sensor, Size 2 FDA UDI
Description: Dental digital intraoral sensor, size 2 FDA UDI

Identifiers

Catalog Number: 213AC25B1 FDA UDI
Primary DI / UDI-DI: D787213AC25B11 FDA UDI
510(k) Number: K013271 FDA UDI
FDA Product Code: MUH FDA UDI
GMDN Term: Dental digital imaging sensor, intraoral 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Liquid Chemical FDA UDI

Dimensions & Sizes

Size: Height — 6.60 Millimeter FDA UDI
Length — 42.80 Millimeter FDA UDI
Width — 30.49 Millimeter FDA UDI

Category: Dental digital imaging sensor, intraoral

Xdr by Cyber Medical Imaging, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental digital imaging sensor, intraoral.

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XIOS XG SELECT — SIRONA DENTAL, INC. · Class II
CDR — SIRONA DENTAL, INC. · Class II
XIOS XG SUPREME — SIRONA DENTAL, INC. · Class II
SCHICK33 — SIRONA DENTAL, INC. · Class II
XIOS XG WIFI — SIRONA DENTAL, INC. · Class II

Cleared under the same submission

K013271 also covers:

XDR — CYBER MEDICAL IMAGING, INC.
XDR — CYBER MEDICAL IMAGING, INC.
XDR — CYBER MEDICAL IMAGING, INC.
XDR — CYBER MEDICAL IMAGING, INC.
XDR — CYBER MEDICAL IMAGING, INC.
XDR CLARITY — CYBER MEDICAL IMAGING, INC.
XDR CLARITY — CYBER MEDICAL IMAGING, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Cyber Medical Imaging, Inc.

Sources (1)

FDA UDI f58ae743-3be6-4bd0-9a6b-dcc67ae170c5 38 fields · synced Jun 8, 2026