Henry Schein

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name: Henry Schein FDA UDI
Generic Name: Orthodontic bracket adhesive FDA UDI
Device Name: Ortho Bracket Adhes Kit FDA UDI
Model / Reference: 1063002 FDA UDI
Description: Ortho Bracket Adhes Kit FDA UDI

Identifiers

Catalog Number: 1063002 FDA UDI
Primary DI / UDI-DI: 00304040005866 FDA UDI
FDA Product Code: EBF FDA UDI
KLE FDA UDI
DYH FDA UDI
GMDN Term: Orthodontic bracket adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
872.3200 FDA UDI
872.3750 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 — 18 Gram FDA UDI
Weight — 9 Gram FDA UDI
Weight — 3 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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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 f47b0da9-749c-4880-b800-99bc7a697aaf 36 fields · synced May 30, 2026