OrthoFlex™

GUDID 10190707106260

OrthoFlex™ Composite .022 UL2 Roth Rx +8° Tor. +9° Ang.(10PK)

ORTHO ORGANIZERS, INC.

Orthodontic bracket, plastic, single-use

• Primary Device ID: 10190707106260
• NIH Device Record Key: c192bdbd-4640-4e86-bb12-5730d10788ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoFlex™
• Version Model Number: COM-112
• 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	00190707106263 [Primary]
GS1	10190707106260 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973776

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 [OrthoFlex™]

• 10190707106772: OrthoFlex™ Round Composite Buttons 10/pk BUTTON
• 10190707106765: OrthoFlex™ Rectangular Composite Buttons 10/pk
• 00190707106072: OrthoFlex™ .022 M 5x5 Hks 345 SPK
• 00190707106065: OrthoFlex™ .022 M 5x5 Hks 3 SPK
• 00190707106058: OrthoFlex™ .018 M 5x5 Hks 345 SPK
• 00190707106041: OrthoFlex™ .018M 5x5 Hks 3 SPK
• 00190707106034: OrthoFlex™ .022 R 5x5 Hks 345 SPK
• 00190707106027: OrthoFlex™ .022 R 5x5 Hks 3 SPK
• 00190707106010: OrthoFlex™ .022 R 5x5 SPK
• 00190707106003: OrthoFlex™ .018 R 5x5 Hks 345 SPK
• 10190707106758: OrthoFlex™ Com McLaughlin .022 LL5 Rx -17° Tor. +2° Ang.(10PK)
• 10190707106741: OrthoFlex™ Com McLaughlin .022 LR5 Rx -17° Tor. +2° Ang.(10PK)
• 10190707106734: OrthoFlex™ Com McLaughlin022 LL5 Hk Rx -17° Tor. +2° Ang.(10PK)
• 10190707106727: OrthoFlex™ Com McLaughlin022 LR5 Hk Rx -17° Tor. +2° Ang.(10PK)
• 10190707106710: OrthoFlex™ Com McLaughlin .022 LL4 Rx -12° Tor. +2° Ang.(10PK)
• 10190707106703: OrthoFlex™ Com McLaughlin .022 LR4 Rx -12° Tor. +2° Ang.(10PK)
• 10190707106697: OrthoFlex™ Com McLaughlin022 LL4 Hk Rx -12° Tor. +2° Ang.(10PK)
• 10190707106680: OrthoFlex™ Com McLaughlin022 LR4 Hk Rx -12° Tor. +2° Ang.(10PK)
• 10190707106673: OrthoFlex™ Com McLaughlin .022 LL3Hk Rx 0° Tor. +3° Ang.(10PK)
• 10190707106666: OrthoFlex™ Com McLaughlin .022 LR3Hk Rx 0° Tor. +3° Ang.(10PK)
• 10190707106659: OrthoFlex™ Com McLaughlin .022 L1/2 Rx -6° Tor. 0° Ang.(10PK)
• 10190707106642: OrthoFlex™ Com McLaughlin022 U4/5Hk Rx -7° Tor. 0° Ang.(10PK)
• 10190707106635: OrthoFlex™ Com McLaughlin .022 U4/5 Rx -7° Tor. 0° Ang.(10PK)
• 10190707106628: OrthoFlex™ Com McLaughlin .022 UL3Hk Rx 0° Tor. +8° Ang.(10PK)
• 10190707106611: OrthoFlex™ Com McLaughlin .022 UR3Hk Rx 0° Tor. +8° Ang.(10PK)
• 10190707106604: OrthoFlex™ Com McLaughlin .022 UL2 Rx +10° Tor. +8° Ang.(10PK)
• 10190707106598: OrthoFlex™ Com McLaughlin .022 UR2 Rx +10° Tor. +8° Ang.(10PK)
• 10190707106581: OrthoFlex™ Com McLaughlin .022 UL1 Rx +17° Tor. +4° Ang.(10PK)
• 10190707106574: OrthoFlex™ Com McLaughlin .022 UR1 Rx +17° Tor. +4° Ang.(10PK)
• 10190707106567: OrthoFlex™ Com McLaughlin .018 LL5 Rx -17° Tor. +2° Ang.(10PK)
• 10190707106550: OrthoFlex™ Com McLaughlin .018 LR5 Rx -17° Tor. +2° Ang.(10PK)
• 10190707106543: OrthoFlex™ Com McLaughlin018 LL5 Hk Rx -17° Tor. +2° Ang.(10PK)
• 10190707106536: OrthoFlex™ Com McLaughlin018 LR5 Hk Rx -17° Tor. +2° Ang.(10PK)
• 10190707106529: OrthoFlex™ Com McLaughlin .018 LL4 Rx -12° Tor. +2° Ang.(10PK)
• 10190707106512: OrthoFlex™ Com McLaughlin .018 LR4 Rx -12° Tor. +2° Ang.(10PK)
• 10190707106505: OrthoFlex™ Com McLaughlin018 LL4 Hk Rx -12° Tor. +2° Ang.(10PK)
• 10190707106499: OrthoFlex™ Com McLaughlin018 LR4 Hk Rx -12° Tor. +2° Ang.(10PK)
• 10190707106482: OrthoFlex™ Com McLaughlin .018 LL3HK Rx 0° Tor. +3° Ang.(10PK)
• 10190707106475: OrthoFlex™ Com McLaughlin .018 LR3HK Rx 0° Tor. +3° Ang.(10PK)
• 10190707106468: OrthoFlex™ Com McLaughlin .018 L1/2 Rx -6° Tor. 0° Ang.(10PK)
• 10190707106451: OrthoFlex™ Com McLaughlin018 U4/5Hk Rx -7° Tor. 0° Ang.(10PK)
• 10190707106444: OrthoFlex™ Com McLaughlin .018 U4/5 Rx -7° Tor. 0° Ang.(10PK)
• 10190707106437: OrthoFlex™ Com McLaughlin .018 UL3HK Rx 0° Tor. +8° Ang.(10PK)
• 10190707106420: OrthoFlex™ Com McLaughlin .018 UR3HK Rx 0° Tor. +8° Ang.(10PK)
• 10190707106413: OrthoFlex™ Com McLaughlin .018 UL2 Rx +10° Tor. +8° Ang.(10PK)
• 10190707106406: OrthoFlex™ Com McLaughlin .018 UR2 Rx +10° Tor. +8° Ang.(10PK)
• 10190707106390: OrthoFlex™ Com McLaughlin .018 UL1 Rx +17° Tor. +4° Ang.(10PK)
• 10190707106383: OrthoFlex™ Com McLaughlin .018 UR1 Rx +17° Tor. +4° Ang.(10PK)
• 10190707106376: OrthoFlex™ Composite .022 L5 Hk Roth Rx -22° Tor. 0° Ang.(10PK)
• 10190707106369: OrthoFlex™ Composite .022 L5 Roth Rx -22° Tor. 0° Ang.(10PK)