Henry Schein

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name: Henry Schein FDA UDI
Generic Name: Dentine bonding agent/set FDA UDI
Device Name: Ortho Bracket Adhes Kit FDA UDI
Model / Reference: 1063732 FDA UDI
Description: Ortho Bracket Adhes Kit FDA UDI

Identifiers

Catalog Number: 1063732 FDA UDI
Primary DI / UDI-DI: 00304040005873 FDA UDI
FDA Product Code: DYH FDA UDI
EBF FDA UDI
KLE FDA UDI
GMDN Term: Dentine bonding agent/set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3750 FDA UDI
872.3690 FDA UDI
872.3200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 9 Gram FDA UDI
Total Volume — 6 Milliliter FDA UDI
Weight — 0.35 Gram FDA UDI

Category: Dentine bonding agent/set Dental etching solution Orthodontic bracket adhesive

Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthodontic bracket adhesive.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Henry Schein, Inc.

Sources (1)

FDA UDI 3250172b-0b0f-44de-93fc-d8d5cf45af30 36 fields · synced May 31, 2026