Mark3

FDA UDI

Class I (US FDA UDI)

by Cargus International, Inc

Identity

Trade Name: MARK3 FDA UDI
Generic Name: Diamond dental bur, reusable FDA UDI
Device Name: Blue Streak Diamond Burs Round Edge Taper 846KR.016 Medium Blue - MARK3® FDA UDI
Model / Reference: 846KR-016M FDA UDI
Description: Blue Streak Diamond Burs Round Edge Taper 846KR.016 Medium Blue - MARK3® FDA UDI

Identifiers

Catalog Number: 846KR-016M FDA UDI
Primary DI / UDI-DI: 00850014374426 FDA UDI
FDA Product Code: EJL FDA UDI
GMDN Term: Diamond dental bur, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3240 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

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Diamond dental bur, reusable

Mark3 by Cargus International, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Diamond dental bur, reusable.

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Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
MAXCUT DIAMOND BURS (6/pk) CRS 6852-012 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
Diatech Diamond Instruments — Coltène/Whaledent AG · Class I
HORICO — Hopf, Ringleb & Co. GmbH & Cie. · Class I

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: Cargus International, Inc

Sources (1)

FDA UDI 2d0a02a7-b9b2-4cab-ac95-73884aa40553 35 fields · synced May 30, 2026