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Filtek™

FDA UDI

Class II (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™ One Capsule, Bulk Fill, Pillow Pack Sample, 4867CP FDA UDI
Model / Reference
4867CP FDA UDI
Description
3M™ ESPE™ Filtek™ One Capsule, Bulk Fill, Pillow Pack Sample, 4867CP FDA UDI

Identifiers

Catalog Number
4867CP FDA UDI
Primary DI / UDI-DI
30605861062337 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental composite resinDentine bonding agent/set

Filtek™ by 3m Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3m Company

Sources (1)

  • FDA UDI 677e9c89-d730-4881-92a0-6239a1119190 35 fields · synced May 30, 2026