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OptiBond Universal

FDA UDI

Class II (US FDA UDI)

by Kerr Corporation

Identity

Trade Name
OptiBond Universal FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Sample Pack – Bonding Agent – 2 Unidose Devices (0.18mL/ each) FDA UDI
Model / Reference
36641 FDA UDI
Description
Sample Pack – Bonding Agent – 2 Unidose Devices (0.18mL/ each) FDA UDI

Identifiers

Primary DI / UDI-DI
00841396121609 FDA UDI
FDA Product Code
KLE FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 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: Dentine bonding agent/set

OptiBond Universal by Kerr Corporation — 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
Kerr Corporation

Sources (1)

  • FDA UDI eaecaff6-3f97-41d3-b574-f59e3d44f339 36 fields · synced Jun 8, 2026