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CLEARFIL™ Universal Bond Kit

FDA UDI

Class II (US FDA UDI)

by Kuraray Noritake Dental Inc.

Identity

Trade Name
CLEARFIL™ Universal Bond Kit FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Bottle Standard Kit FDA UDI
Model / Reference
#3290-KA FDA UDI
Description
Bottle Standard Kit FDA UDI

Identifiers

Primary DI / UDI-DI
EKUR003290KA1 FDA UDI
FDA Product Code
LBH FDA UDI
KLE FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3260 FDA UDI
872.3200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Dentine bonding agent/set

CLEARFIL™ Universal Bond Kit by Kuraray Noritake Dental Inc. — 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
Kuraray Noritake Dental Inc.

Sources (1)

  • FDA UDI 71bc117f-f8a8-4e2b-ad12-f2d0ededaf43 33 fields · synced Jun 8, 2026