Apex

FDA UDI

Class II (US FDA UDI)

by Masterlink, LLC

Identity

Trade Name: Apex FDA UDI
Generic Name: Dental digital imaging sensor, intraoral FDA UDI
Device Name: Size #2 Adult Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure. FDA UDI
Model / Reference: S11685-12-71 FDA UDI
Description: Size #2 Adult Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure. FDA UDI

Identifiers

Primary DI / UDI-DI: D875S11685127105 FDA UDI
510(k) Number: K163282 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: Length — 41.9 Millimeter FDA UDI
Width — 30.4 Millimeter FDA UDI

Category: Dental digital imaging sensor, intraoral

Apex by Masterlink, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental digital imaging sensor, intraoral.

DC-Air™ Intraoral Sensor — Athlos Oy · Class II
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

Cleared under the same submission

K163282 also covers:

Apex — Masterlink, LLC

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

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

Manufacturer

Manufacturer: Masterlink, LLC

Sources (1)

FDA UDI 3ac281f9-f1fc-4e3f-9521-d6a7c2b226fe 37 fields · synced May 30, 2026