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Z Bond-Visible Light Cure One-Step Bonding Adhesive

FDA UDI

Class II (US FDA UDI)

by Dent Zar, Inc.

Identity

Trade Name
Z Bond-Visible Light Cure One-Step Bonding Adhesive FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Dent Zar’s Z-Bond is a One-Step Light-Cured Self-Etching Dentin/Enamel Bonding Adhesive, which releases fluorides and does not require mixing, because the adhesive combines properties of etching and bonding in a single bottle. The result is fast and saves chair time. Z-Bond markedly reduces sensitivity due to the fact that the adhesive penetrates the smear layer and adheres to the tooth structure without opening tubules. The work effort is significantly reduced and simplified with Z Bond. All adhesive treatment steps are included in one component. Z Bond is a 7th generation of bonding dentin/enamel adhesives. Z Bond is designed to promote adhesion to tooth structure in the following applications: FDA UDI
Model / Reference
0021 FDA UDI
Description
Dent Zar’s Z-Bond is a One-Step Light-Cured Self-Etching Dentin/Enamel Bonding Adhesive, which releases fluorides and does not require mixing, because the adhesive combines properties of etching and bonding in a single bottle. The result is fast and saves chair time. Z-Bond markedly reduces sensitivity due to the fact that the adhesive penetrates the smear layer and adheres to the tooth structure without opening tubules. The work effort is significantly reduced and simplified with Z Bond. All adhesive treatment steps are included in one component. Z Bond is a 7th generation of bonding dentin/enamel adhesives. Z Bond is designed to promote adhesion to tooth structure in the following applications: FDA UDI

Identifiers

Catalog Number
0021 FDA UDI
Primary DI / UDI-DI
D83600210 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

Yes

FDA UDI

Category: Dentine bonding agent/set

Z Bond-Visible Light Cure One-Step Bonding Adhesive by Dent Zar, 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
Dent Zar, Inc.

Sources (1)

  • FDA UDI fb4b6d57-3cd0-4060-8b93-e2d382726dad 34 fields · synced Jun 8, 2026