Power Bond

GUDID 00190707000707

POWER BOND LIGHT-CURED BONDING CONDITIONER

ORTHO ORGANIZERS, INC.

Orthodontic bracket adhesive

• Primary Device ID: 00190707000707
• NIH Device Record Key: 0fb6b71a-6fe3-42c0-801f-7dd9c04b5648
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Power Bond
• Version Model Number: 471-062
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
GS1	00190707000707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935625

FDA Product Code

• DYH: ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by ORTHO ORGANIZERS, INC.

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• 10190707086494 - Triumph®: 2026-01-15 Triumph® Safety Hold Replacement Silicone Insert
• 00190707086503 - Triumph®: 2026-01-15 Triumph® Adhesive Remover - Replacement Blade
• 10190707086517 - Triumph®: 2026-01-15 Triumph® Adhesive Remover - 1/4" Replacement Pads
• 10190707086524 - Triumph®: 2026-01-15 Triumph® Band Remover - 3/16" Replacement Pads
• 10190707086531 - Triumph®: 2026-01-15 Triumph® Band Remover - 1/4" Replacement Pads
• 00190707102975 - Carriere® Motion Pro™: 2026-01-13 Carriere® Motion Pro™ Clear Bite Corrector 18 mm 1-Set
• 00190707103002 - Carriere® Motion Pro™: 2026-01-13 Carriere® Motion Pro™ Clear Bite Corrector 20 mm 1-Set