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Spectrum

FDA UDI

Class I (US FDA UDI)

by Ortho Arch Company Inc

Identity

Trade Name
SPECTRUM FDA UDI
Generic Name
Orthodontic appliance remover FDA UDI
Device Name
SPECTRUM POSTERIOR BAND REMOVER FDA UDI
Model / Reference
POSTERIOR BAND REMOVER FDA UDI
Description
SPECTRUM POSTERIOR BAND REMOVER FDA UDI

Identifiers

Catalog Number
800-009 FDA UDI
Primary DI / UDI-DI
D9098000091 FDA UDI
FDA Product Code
JEX FDA UDI
GMDN Term
Orthodontic appliance remover 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthodontic appliance remover

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

Similar devices

Also classified as Orthodontic appliance remover.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Arch Company Inc

Sources (1)

  • FDA UDI a56dc55e-d955-413a-8e1a-02adb8bd3367 35 fields · synced May 30, 2026