DynaFlex Power Chain Long

GUDID D8411234XX1

Ortho Solutions, LC

Orthodontic inter-bracket elastic chain

• Primary Device ID: D8411234XX1
• NIH Device Record Key: 9200b8d5-62c4-4d75-a8db-85539f3c9818
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaFlex Power Chain Long
• Version Model Number: 1
• Company DUNS: 006335558
• Company Name: Ortho Solutions, LC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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
HIBCC	D8411234XX1 [Primary]

FDA Product Code

• ECI: Band, Elastic, 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: 2025-07-08
• Device Publish Date: 2025-06-30

Devices Manufactured by Ortho Solutions, LC

• D841092162001 - Norris Extra Broad Archwire: 2025-07-08 NiTi round .014 archwire
• D841092163001 - Norris Extra Broad Archwire: 2025-07-08 NiTi, round .016 archwire
• D841092263001 - Norris Extra Broad Archwire: 2025-07-08 NiTi rectangular archwire
• D841092266001 - Norris Extra Broad Archwire: 2025-07-08
• D841093267001 - Norris Extra Broad Archwire: 2025-07-08
• D8411219XX1 - DynaFlex D20 Ties: 2025-07-08 Orthodontic elastomeric ligature ties
• D8411234XX1 - DynaFlex Power Chain Long: 2025-07-08
• D8411234XX1 - DynaFlex Power Chain Long: 2025-07-08
• D841092164001 - Norris Extra Broad Archwire: 2025-07-07 NiTi .018 round archwire