OptiBand

FDA UDI

Class II (US FDA UDI)

by Ormco Corporation

Identity

Trade Name: OptiBand FDA UDI
Generic Name: Orthodontic bracket adhesive FDA UDI
Device Name: Band Cement - Dual Syringe Kit FDA UDI
Model / Reference: 740-0194 FDA UDI
Description: Band Cement - Dual Syringe Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 00889989061628 FDA UDI
510(k) Number: K924151 FDA UDI
FDA Product Code: DYH FDA UDI
GMDN Term: Orthodontic bracket adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3750 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 20 Gram FDA UDI

Category: Orthodontic bracket adhesive

OptiBand by Ormco Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket adhesive.

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ORTHOSOURCE — Ortho Source
Resilience — ORTHO TECHNOLOGY, INC. · Class II
Illuminate — Ortho Organizers, Inc. · Class II
Novocol GRANITEC PRIMER 9ML — Septodont · Class II
Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Light Cure Retainer — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II

Cleared under the same submission

K924151 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Ormco Corporation

Sources (1)

FDA UDI d393b6f7-9930-4b4b-9916-93108ba7a652 37 fields · synced Jun 9, 2026