Reflections®

GUDID 10190707107045

Reflections® .022 L4 Roth Rx -17° Tor. 0° Ang.(10PK)

ORTHO ORGANIZERS, INC.

Orthodontic bracket, plastic, single-use

• Primary Device ID: 10190707107045
• NIH Device Record Key: 5cf30943-3867-4b90-911e-6481dd8e61cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reflections®
• Version Model Number: REF-160
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190707107048 [Primary]
GS1	10190707107045 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922499

FDA Product Code

• DYW: BRACKET, PLASTIC, ORTHODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-06
• Device Publish Date: 2025-09-26

On-Brand Devices [Reflections®]

• 00190707107406: Reflections® .022 M 5x5 Hks345 SPK REFLECTIONS
• 00190707107390: Reflections® .022 M 5x5 Hks 3 SPK REFLECTIONS
• 00190707107383: Reflections® .018 M 5x5 Hks345 SPK REFLECTIONS
• 00190707107376: Reflections® .018 M 5x5 Hks 3 SPK REFLECTIONS
• 00190707107369: Reflections® .022 R 3x3 Hks 3 SPK REFLECTIONS
• 00190707107352: Reflections® .022 R 5x5 Hks345 SPK Upper Only
• 00190707107345: Reflections® .022 R 5x5 Hks 3 SPK Upper Only
• 00190707107338: Reflections® .022 R 5x5 Hks 345 SPK REFLECTIONS
• 00190707107321: Reflections® .022 R 5x5 Hks 3 SPK REFLECTIONS
• 00190707107314: Reflections® .018 R 3x3 Hks 3 SPK REFLECTIONS
• 00190707107307: Reflections® .018 R 5x5 Hks345 SPK Upper Only
• 00190707107291: Reflections® .018 R 5x5 Hks 3 SPK Upper Only
• 00190707107284: Reflections® .018 R 5x5 Hks 345 SPK REFLECTIONS
• 00190707107277: Reflections® .018 R 5x5 Hks 3 SPK
• 10190707107267: Reflections® Cer McLaughlin .022 LL5 Rx -17° Tor. +2° Ang.(10PK)
• 10190707107250: Reflections® Cer McLaughlin .022 LR5 Rx -17° Tor. +2° Ang.(10PK)
• 10190707107243: Reflections® Cer McLaughlin .022 LL5 Hk Rx -17° Tor. +2° Ang.(10PK)
• 10190707107236: Reflections® Cer McLaughlin .022 LR5 Hk Rx -17° Tor. +2° Ang.(10PK)
• 10190707107229: Reflections® Cer McLaughlin .022 LL4 Rx -12° Tor. +2° Ang.(10PK)
• 10190707107212: Reflections® Cer McLaughlin .022 LR4 Rx -12° Tor. +2° Ang.(10PK)
• 10190707107205: Reflections® Cer McLaughlin .022 LL4 Hk Rx -12° Tor. +2° Ang.(10PK)
• 10190707107199: Reflections® Cer McLaughlin .022 LR4 Hk Rx -12° Tor. +2° Ang.(10PK)
• 10190707107182: Reflections® Cer McLaughlin .022 LL3HK Rx 0° Tor. +3° Ang.(10PK)
• 10190707107175: Reflections® Cer McLaughlin .022 LR3HK Rx 0° Tor. +3° Ang.(10PK)
• 10190707107168: Reflections® Cer McLaughlin .022 L1/2 Rx -6° Tor. 0° Ang.(10PK)
• 10190707107151: Reflections® Cer McLaughlin .022 U4/5Hk Rx -7° Tor. 0° Ang.(10PK)
• 10190707107144: Reflections® Cer McLaughlin .022 U4/5 Rx -7° Tor. 0° Ang.(10PK)
• 10190707107137: Reflections® Cer McLaughlin .022 UL3HK Rx 0° Tor. +8° Ang.(10PK)
• 10190707107120: Reflections® Cer McLaughlin .022 UR3HK Rx 0° Tor. +8° Ang.(10PK)
• 10190707107113: Reflections® Cer McLaughlin .022 UL2 Rx +10° Tor. +8° Ang.(10PK)
• 10190707107106: Reflections® Cer McLaughlin .022 UR2 Rx +10° Tor. +8° Ang.(10PK)
• 10190707107090: Reflections® Cer McLaughlin .022 UL1 Rx +17° Tor. +4° Ang.(10PK)
• 10190707107083: Reflections® Cer McLaughlin .022 UR1 Rx +17° Tor. +4° Ang.(10PK)
• 10190707107076: Reflections® .022 L5 Hk Roth Rx -22° Tor. 0° Ang.(10PK)
• 10190707107069: Reflections® .022 L5 Roth Rx -22° Tor. 0° Ang.(10PK)
• 10190707107052: Reflections® .022 L4 Hk Roth Rx -17° Tor. 0° Ang.(10PK)
• 10190707107045: Reflections® .022 L4 Roth Rx -17° Tor. 0° Ang.(10PK)
• 10190707107038: Reflections® .022 LL3 Hk Roth Rx -11° Tor. +5° Ang.(10PK)
• 10190707107021: Reflections® .022 LR3 Hk Roth Rx -11° Tor. +5° Ang.(10PK)
• 10190707107014: Reflections® .022 L1/2 Roth Rx 0° Tor. 0° Ang.(10PK)
• 10190707107007: Reflections® .022 U4/5 Hk Roth Rx -7° Tor. 0° Ang.(10PK)
• 10190707106994: Reflections® .022 U4/5 Roth Rx -7° Tor. 0° Ang.(10PK)
• 10190707106987: Reflections® .022 UL3 Hk Roth Rx 0° Tor. +11° Ang.(10PK)
• 10190707106970: Reflections® .022 UR3 Hk Roth Rx 0° Tor. +11° Ang.(10PK)
• 10190707106963: Reflections® .022 UL2 Roth Rx +8° Tor. +9° Ang.(10PK)
• 10190707106956: Reflections® .022 UR2 Roth Rx +8° Tor. +9° Ang.(10PK)
• 10190707106949: Reflections® .022 UL1 Roth Rx +12° Tor. +5° Ang.(10PK)
• 10190707106932: Reflections® .022 UR1 Roth Rx +12° Tor. +5° Ang.(10PK)
• 10190707106925: Reflections® .018 L5 Hk Roth Rx -22° Tor. 0° Ang.(10PK)
• 10190707106918: Reflections® .018 L5 Roth Rx -22° Tor. 0° Ang.(10PK)