Ortho Arch

FDA UDI

Class I (US FDA UDI)

by Ortho Arch Company Inc

Identity

Trade Name: ORTHO ARCH FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: REDI SET LED LIGHT FDA UDI
Model / Reference: 800-511 FDA UDI
Description: REDI SET LED LIGHT FDA UDI

Identifiers

Primary DI / UDI-DI: D90980051112 FDA UDI
FDA Product Code: ECP FDA UDI
GMDN Term: Dental/surgical polymerization lamp 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: Dental/surgical polymerization lamp

Ortho Arch 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 8209cf4e-da77-4c5a-b2e8-dd0a7d58e42b 33 fields · synced Jun 6, 2026