CoJet™

FDA UDI

Class II (US FDA UDI)

by 3M Deutschland GmbH

Identity

Trade Name: CoJet™ FDA UDI
Generic Name: Dentine bonding agent/set FDA UDI
Device Name: 3M™ ESPE™ CoJet™ System Intro Kit, 68421 FDA UDI
Model / Reference: 68421 FDA UDI
Description: 3M™ ESPE™ CoJet™ System Intro Kit, 68421 FDA UDI

Identifiers

Catalog Number: 68421 FDA UDI
Primary DI / UDI-DI: 04035077001588 FDA UDI
FDA Product Code: KLE FDA UDI
EBF FDA UDI
GMDN Term: Dentine bonding agent/set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3200 FDA UDI
872.3690 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dentine bonding agent/set Denture reliner, hard Dental composite resin kit

CoJet™ by 3M Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental composite resin kit.

Hexa — Hexa Dental · Class II
AxioComp NT — Axiodent Inc. · Class II
Hexa — Hexa Dental · Class II
PANAVIA™ V5 — KURARAY NORITAKE DENTAL INC. · Class II
Hexa — Hexa Dental · Class II
PANAVIA™ V5 — KURARAY NORITAKE DENTAL INC. · Class II
Hexa — Hexa Dental · Class II
Magma NT — PREVEST DENPRO LIMITED · 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

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

Manufacturer

Manufacturer: 3M Deutschland GmbH

Sources (1)

FDA UDI c2e079ab-814b-4cbe-976a-aed8eed7f4d2 35 fields · synced May 30, 2026