Pure

FDA UDI

Class II (US FDA UDI)

by Ortho Technology, Inc.

Identity

Trade Name: PURE FDA UDI
Generic Name: Orthodontic bracket, ceramic FDA UDI
Device Name: PURE® Roth 022 L5 Rx -21º Tor. 0º Ang.(10PK) FDA UDI
Model / Reference: S22170 FDA UDI
Description: PURE® Roth 022 L5 Rx -21º Tor. 0º Ang.(10PK) FDA UDI

Identifiers

Primary DI / UDI-DI: 00190730003775 FDA UDI
510(k) Number: K073045 FDA UDI
FDA Product Code: NJM FDA UDI
GMDN Term: Orthodontic bracket, ceramic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5470 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

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic bracket, ceramic

Pure by Ortho Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket, ceramic.

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Experience — GC Orthodontics America Inc. · Class II
Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
APC™ II Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
EXPERIENCE® — GC Orthodontics America Inc. · Class II
APC™ PLUS Clarity™ SL — 3M UNITEK CORPORATION · Class II

Cleared under the same submission

K073045 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: Ortho Technology, Inc.

Sources (1)

FDA UDI 02114f47-8807-4e74-95d5-e1a5fcd09e2f 34 fields · synced Jun 1, 2026