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EZ Bond Universal (EZB15)

FDA UDI

Class II (US FDA UDI)

by Meta Biomed, Inc.

Identity

Trade Name
EZ Bond Universal (EZB15) FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component. EZB15 (1.5g) FDA UDI
Model / Reference
6008 FDA UDI
Description
EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component. EZB15 (1.5g) FDA UDI

Identifiers

Primary DI / UDI-DI
08806387860082 FDA UDI
510(k) Number
K230009 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

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

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

EZ Bond Universal (EZB15) by Meta Biomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Cleared under the same submission

K230009 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meta Biomed, Inc.

Sources (1)

  • FDA UDI 8f9a8d49-fb8b-4374-9109-2a278401916d 34 fields · synced May 29, 2026