Bio-Optima™

FDA UDI

Class I (US FDA UDI)

by Orthodontic Supply & Equipment Co., Inc.

Identity

Trade Name: BIO-OPTIMA™ FDA UDI
Generic Name: Orthodontic archwire FDA UDI
Device Name: Multi-force Thermal Nickel Titanium Archwire Natural Form .019 x .025 Lower FDA UDI
Model / Reference: 0550-700 FDA UDI
Description: Multi-force Thermal Nickel Titanium Archwire Natural Form .019 x .025 Lower FDA UDI

Identifiers

Primary DI / UDI-DI: 00810042124349 FDA UDI
FDA Product Code: DZC FDA UDI
GMDN Term: Orthodontic archwire 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

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 archwire

Bio-Optima™ by Orthodontic Supply & Equipment Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthodontic archwire.

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EUROPA SOLO-PACK — G&H Wire Company, Inc. · Class I
A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE SOLO-PACK — G&H Wire Company, Inc. · Class I
Masel — Ortho Organizers, Inc. · Class I
Stainless Steel Archwires — Ortho Organizers, Inc. · Class I
G4 EUROPA NICKEL TITANIUM — G&H Wire 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: Orthodontic Supply & Equipment Co., Inc.

Sources (1)

FDA UDI a56af242-fb0a-4665-9b12-9e4e6586c0c1 33 fields · synced May 30, 2026