Max-Bond

FDA UDI

Class II (US FDA UDI)

by Ortho Pro Dent LLC

Identity

Trade Name: MAX-BOND FDA UDI
Generic Name: Orthodontic bracket adhesive FDA UDI
Device Name: Orthodontic light cure Band Cement kit contains 1 x4.5 gm Base syringe & 1 x 4.5 gm Catalyst FDA UDI
Model / Reference: OP963A-01 FDA UDI
Description: Orthodontic light cure Band Cement kit contains 1 x4.5 gm Base syringe & 1 x 4.5 gm Catalyst FDA UDI

Identifiers

Primary DI / UDI-DI: 00810152820070 FDA UDI
510(k) Number: K112574 FDA UDI
FDA Product Code: EMA FDA UDI
GMDN Term: Orthodontic bracket adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3275 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic bracket adhesive

Max-Bond by Ortho Pro Dent LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket adhesive.

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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

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: Ortho Pro Dent LLC

Sources (1)

FDA UDI 3b4b98ab-b2bf-4701-9ee9-76e80437615e 36 fields · synced May 30, 2026