EDLENi Dental Sensor - Size 1

FDA UDI

Class II (US FDA UDI)

by Edlen Imaging, LLC

Identity

Trade Name: EDLENi Dental Sensor - Size 1 FDA UDI
Generic Name: Dental digital imaging sensor, intraoral FDA UDI
Device Name: EDLENi Dental Sensor, CMOS Image Sensor, CsI Scintillator, 2.5 meter cable FDA UDI
Model / Reference: S11684-16-43 FDA UDI
Description: EDLENi Dental Sensor, CMOS Image Sensor, CsI Scintillator, 2.5 meter cable FDA UDI

Identifiers

Primary DI / UDI-DI: 00862973000346 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

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 39 Millimeter FDA UDI
Width — 25 Millimeter FDA UDI

Category: Dental digital imaging sensor, intraoral

EDLENi Dental Sensor - Size 1 by Edlen Imaging, LLC — 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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WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
Schick — Dentsply International · Class II
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

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: Edlen Imaging, LLC

Sources (1)

FDA UDI 12d19d21-0ca4-46c7-92f3-25ec33cc5dc7 36 fields · synced May 30, 2026