Second Molar Single Tube

FDA UDI

Class I (US FDA UDI)

by Tp Orthodontics, Inc.

Identity

Trade Name: Second Molar Single Tube FDA UDI
Generic Name: Orthodontic tube FDA UDI
Device Name: UL 2nd Molar W/O Distal Extension Torque -10, Tip 0, Distal Offset 14 0.56 mm x 0.71 mm (.022" x .028") 3.3 mm FDA UDI
Model / Reference: 391-400 FDA UDI
Description: UL 2nd Molar W/O Distal Extension Torque -10, Tip 0, Distal Offset 14 0.56 mm x 0.71 mm (.022" x .028") 3.3 mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00192029024539 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic tube

Second Molar Single Tube by Tp Orthodontics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Tp Orthodontics, Inc.

Sources (1)

FDA UDI b948cc77-3905-4f6b-b42e-b472b7514fd9 33 fields · synced May 31, 2026