BONDPRO™ PLASTIC ENHANCER 10cc

GUDID 10190886000595

PLASTIC ENHANCER 10cc. APPLIED PRIOR TO BONDING FOR STRONGER BONDS.

G & H Wire Company, Inc.

Dentine bonding agent/set

• Primary Device ID: 10190886000595
• NIH Device Record Key: cbc7e964-a688-4fee-af25-70fbc1151287
• Commercial Distribution Discontinuation: 2017-09-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BONDPRO™ PLASTIC ENHANCER 10cc
• Version Model Number: M957-01
• Company DUNS: 831465641
• Company Name: G & H Wire Company, Inc.
• Device Count: 1
• 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: false
• 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

Customer Support Contacts

• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190886000595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981036

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: 5
• Public Version Date: 2024-02-16
• Device Publish Date: 2016-09-24

Devices Manufactured by G & H Wire Company, Inc.

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• 10190886051290 - NA: 2025-04-08 WHITE COATED FACEBOW, UNIV
• 10190886051306 - NA: 2025-04-08 ORANGE COATED FACEBOW, UNIV
• 10190886051313 - NA: 2025-04-08 DARK GREEN COATED FACEBOW, UNIV
• 10190886051320 - NA: 2025-04-08 LIME GREEN COATED FACEBOW, UNIV
• 10190886051337 - NA: 2025-04-08 YELLOW COATED FACEBOW, UNIV
• 10190886051344 - NA: 2025-04-08 PURPLE COATED FACEBOW, UNIV