BONDPRO™ LIGHT ACTIVATED ADHES 1-5gm SYRINGE KIT

FDA UDI

Class II (US FDA UDI)

by G&H Wire Company, Inc.

Identity

Trade Name: BONDPRO™ LIGHT ACTIVATED ADHES 1-5gm SYRINGE KIT FDA UDI
Generic Name: Orthodontic bracket adhesive FDA UDI
Device Name: Intro Kit. A unique light activated composite resin system for bonding plastic, metal or porcelain orthodontic brackets to etched enamel. Kit contents: 1x 5gm syringe, 3ml liquid etchant, 3ml resin, instructions. FDA UDI
Model / Reference: M970K-01 FDA UDI
Description: Intro Kit. A unique light activated composite resin system for bonding plastic, metal or porcelain orthodontic brackets to etched enamel. Kit contents: 1x 5gm syringe, 3ml liquid etchant, 3ml resin, instructions. FDA UDI

Identifiers

Primary DI / UDI-DI: 10190886000656 FDA UDI
510(k) Number: K981036 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

Yes

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

Yes

FDA UDI

Category: Orthodontic bracket adhesive

BONDPRO™ LIGHT ACTIVATED ADHES 1-5gm SYRINGE KIT by G&H Wire Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthodontic bracket adhesive.

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Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
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Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II

Cleared under the same submission

K981036 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: G&H Wire Company, Inc.

Sources (1)

FDA UDI 0ce168f7-1f82-474e-8c4b-0a9883526d18 36 fields · synced Jun 8, 2026