Pro-Max

FDA UDI

Class I (US FDA UDI)

by Ortho Pro Dent LLC

Identity

Trade Name: Pro-Max FDA UDI
Generic Name: Orthodontic tube FDA UDI
Device Name: Bondable buccal tube 2nd Molar Non Convertible ,MBT ,Slot .022" , kit 40 pcs, UR,UL,LR,LL , 10 Pcs /each FDA UDI
Model / Reference: BBT2-40-0M FDA UDI
Description: Bondable buccal tube 2nd Molar Non Convertible ,MBT ,Slot .022" , kit 40 pcs, UR,UL,LR,LL , 10 Pcs /each FDA UDI

Identifiers

Primary DI / UDI-DI: 00810152825174 FDA UDI
FDA Product Code: DZD FDA UDI
GMDN Term: Orthodontic tube 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic tube

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

Similar devices

Also classified as Orthodontic tube.

Master Series Bracket — American Orthodontics · Class IIa
Metal brackets conventional milled — Bernhard Förster GmbH · Class IIa
Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
Metal bracket conventional — Bernhard Förster GmbH · Class IIa
Master Series Bracket — American Orthodontics · Class IIa
CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
V-Slot — ASTAR ORTHODONTICS INC. · Class IIa

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 Pro Dent LLC

Sources (1)

FDA UDI 132824ec-9c2a-4529-b913-2dda46f8fa95 35 fields · synced May 31, 2026