C246.fg.012

FDA UDI

Class I (US FDA UDI)

by Jota AG

Identity

Trade Name: C246.FG.012 FDA UDI
Generic Name: Carbide dental bur, reusable FDA UDI
Device Name: Carbide FDA UDI
Model / Reference: C246.FG.012 FDA UDI
Description: Carbide FDA UDI

Identifiers

Primary DI / UDI-DI: EJOT500314496071012 FDA UDI
FDA Product Code: DZA FDA UDI
GMDN Term: Carbide dental bur, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4130 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Carbide dental bur, reusable

C246.fg.012 by Jota AG — 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: Jota AG

Sources (1)

FDA UDI 9568f0a5-70e2-4acf-adf9-fa1bbac1140a 33 fields · synced Jun 8, 2026