Filtek™

FDA UDI

Class I (US FDA UDI)

by 3m Company

Identity

Trade Name: Filtek™ FDA UDI
Generic Name: Dentine bonding agent/set FDA UDI
Device Name: 3M™ ESPE™ Filtek™ Supreme Ultra Universal and Flowable Restoratives, 6029PP FDA UDI
Model / Reference: 6029PP FDA UDI
Description: 3M™ ESPE™ Filtek™ Supreme Ultra Universal and Flowable Restoratives, 6029PP FDA UDI

Identifiers

Catalog Number: 6029PP FDA UDI
Primary DI / UDI-DI: 30605861012936 FDA UDI
FDA Product Code: EID FDA UDI
EBF FDA UDI
KLE FDA UDI
GMDN Term: Dentine bonding agent/set FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
872.3690 FDA UDI
872.3200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: Dental composite resin Dentine bonding agent/set Dental material injection cannula, single-use

Filtek™ by 3m Company — 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: 3m Company

Sources (1)

FDA UDI fae6e11b-5fb8-4675-93a1-d058746736b5 35 fields · synced Jun 1, 2026