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Reflections

FDA UDI

Class II (US FDA UDI)

by Ortho Technology, Inc.

Identity

Trade Name
Reflections FDA UDI
Generic Name
Orthodontic bracket, ceramic FDA UDI
Device Name
Reflections V-Slot 022 UR3 Hk Roth Rx 0° Tor. +11° Ang.(10PK) FDA UDI
Model / Reference
REF-621 FDA UDI
Description
Reflections V-Slot 022 UR3 Hk Roth Rx 0° Tor. +11° Ang.(10PK) FDA UDI

Identifiers

Primary DI / UDI-DI
00190730005984 FDA UDI
510(k) Number
K922499 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Reflecting on the latest advancements in orthodontic treatment, Reflections offers a unique ceramic orthodontic bracket solution. Designed to be bonded directly to teeth for precise pressure application, this single-patient device is ideal for single-use duration and subsequent disposal.

Cleared under the same submission

K922499 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Technology, Inc.

Sources (1)

  • FDA UDI cff80e1a-1e9b-4cce-9969-de7db8606abc 35 fields · synced Jul 30, 2026