Direct Bond Button

FDA UDI

Class I (US FDA UDI)

by Ortho Arch Company Inc

Identity

Trade Name: DIRECT BOND BUTTON FDA UDI
Generic Name: Orthodontic aligner auxiliary attachment kit FDA UDI
Device Name: CERAMIC DIRECT BOND BUTTON (10) FDA UDI
Model / Reference: 270-202 FDA UDI
Description: CERAMIC DIRECT BOND BUTTON (10) FDA UDI

Identifiers

Catalog Number: 270-202 FDA UDI
Primary DI / UDI-DI: D90927020210 FDA UDI
FDA Product Code: ECQ FDA UDI
GMDN Term: Orthodontic aligner auxiliary attachment kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic aligner auxiliary attachment kit

Direct Bond Button by Ortho Arch Company Inc — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Ortho Arch Company Inc

Sources (1)

FDA UDI 9b7c70cf-c4df-40ab-8aff-b10a18642df4 34 fields · synced May 30, 2026