Elite

FDA UDI

Class I (US FDA UDI)

by Ortho Organizers, Inc.

Identity

Trade Name: Elite FDA UDI
Generic Name: Orthodontic metal band FDA UDI
Device Name: Elite ASM 022 ROTH LR6 CONV STD -25T 0A 4DOff CLT 39.5 FDA UDI
Model / Reference: 900-12181-395-3 FDA UDI
Description: Elite ASM 022 ROTH LR6 CONV STD -25T 0A 4DOff CLT 39.5 FDA UDI

Identifiers

Primary DI / UDI-DI: 00190707029654 FDA UDI
FDA Product Code: ECM FDA UDI
GMDN Term: Orthodontic metal band FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5410 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 metal band

Elite by Ortho Organizers, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthodontic metal band.

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CONLIN MOLAR BANDS — ORTHO ARCH COMPANY INC · Class I
TruFit 2.0 — ORTHO TECHNOLOGY, INC. · Class I
Ortho Pro — Ortho Pro Dent LLC · Class I
3M™ Unitek™ — 3M UNITEK CORPORATION · Class I
Bands & Attachments — World Class Technology Corporation · 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 Organizers, Inc.

Sources (1)

FDA UDI ba532eb8-3e80-4006-9389-15474e9f70c2 33 fields · synced Jun 9, 2026