Ortho Arch

FDA UDI

Class I (US FDA UDI)

by Ortho Arch Company Inc

Identity

Trade Name: Ortho Arch FDA UDI
Generic Name: Orthodontic chin cap/cup FDA UDI
Device Name: MULTI ADJUSTABLE FACEMASK PEARL FDA UDI
Model / Reference: 550-102 FDA UDI
Description: MULTI ADJUSTABLE FACEMASK PEARL FDA UDI

Identifiers

Primary DI / UDI-DI: D9095501020 FDA UDI
FDA Product Code: EIG FDA UDI
GMDN Term: Orthodontic chin cap/cup 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

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 chin cap/cup

Ortho Arch by Ortho Arch Company Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic chin cap/cup.

Headgear — Suzhou Yuyue Medical Technology Co., Ltd. · Class I
OrthoQuest — Young Innovations, Inc. · Class II
DTC — Hangzhou DTC Medical Apparatus Co., Ltd. · Class I
Headgear — Suzhou Yuyue Medical Technology Co., Ltd. · Class I
Ortho Arch — ORTHO ARCH COMPANY INC · Class I
Ortho Arch — ORTHO ARCH COMPANY INC · Class I
Ortho Arch — ORTHO ARCH COMPANY INC · Class I
MULTI ADJUSTABLE FACEMASK — ORTHO ARCH COMPANY INC · Class I

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 6526fa6a-5987-4445-9d55-b12d5479008e 33 fields · synced Jun 8, 2026