ApexPilot

FDA UDI

Class I (US FDA UDI)

by Beyes Dental Canada Inc

Identity

Trade Name: ApexPilot FDA UDI
Generic Name: Endodontic apex locator FDA UDI
Device Name: ApexPilot All-In-One, Cordless Endodontic Handpiece, Built-in Apex Locator FDA UDI
Model / Reference: AL2020 FDA UDI
Description: ApexPilot All-In-One, Cordless Endodontic Handpiece, Built-in Apex Locator FDA UDI

Identifiers

Catalog Number: ApexPilot All-In-One FDA UDI
Primary DI / UDI-DI: 00990010301337 FDA UDI
FDA Product Code: EKR FDA UDI
GMDN Term: Endodontic apex locator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Endodontic apex locator

ApexPilot by Beyes Dental Canada Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Beyes Dental Canada Inc

Sources (1)

FDA UDI 83c4bc2a-b640-4eaa-b6a7-a29b5c301665 34 fields · synced May 31, 2026