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.

• 00190707066406 - STAINLESS STEEL BRIGHT PRO FORM™ ARCHWIRE: 2025-03-03 .020 Lower Stainless Steel Bright Pro Form™ Archwires
• 00190707066413 - STAINLESS STEEL BRIGHT PRO FORM™ ARCHWIRE: 2025-03-03 .016 X .016 Lower Stainless Steel Bright Pro Form™ Archwires
• 00190707066420 - STAINLESS STEEL BRIGHT PRO FORM™ ARCHWIRE: 2025-03-03 .016 X .022 Lower Stainless Steel Bright Pro Form™ Archwires
• 00190707066437 - STAINLESS STEEL BRIGHT PRO FORM™ ARCHWIRE: 2025-03-03 .017 X .025 Lower Stainless Steel Bright Pro Form™ Archwires
• 00190707066444 - STAINLESS STEEL BRIGHT PRO FORM™ ARCHWIRE: 2025-03-03 .018 X .025 Lower Stainless Steel Bright Pro Form™ Archwires
• 00190707066451 - STAINLESS STEEL BRIGHT PRO FORM™ ARCHWIRE: 2025-03-03 .019 X .025 Lower Stainless Steel Bright Pro Form™ Archwires
• 00190707066468 - STAINLESS STEEL BRIGHT PRO FORM™ ARCHWIRE: 2025-03-03 .021 X .025 Lower Stainless Steel Bright Pro Form™ Archwires
• 00190707066475 - STAINLESS STEEL BRIGHT PRO FORM™ ARCHWIRE: 2025-03-03 .012 Upper Stainless Steel Bright Pro Form™ Archwires