Bonding Accessories

GUDID 00192029000267

Porcelain Primer

TP ORTHODONTICS INC

Orthodontic bracket adhesive

• Primary Device ID: 00192029000267
• NIH Device Record Key: 6d4a2d81-6fc0-4414-a211-b722a97b07b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bonding Accessories
• Version Model Number: 150-810
• Company DUNS: 005432299
• Company Name: TP ORTHODONTICS INC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029000267 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-09
• Device Publish Date: 2022-02-01

On-Brand Devices [Bonding Accessories]

• 00192029000267: Porcelain Primer
• 00192029000250: Right-On Enamel Cond
• 00192029000243: TPO Blue Etchant Gel
• 00192029000236: TPO Blue Etchant Gel
• 00192029000212: Enamel Conditioner S
• 00192029000205: Enamel Conditioner G
• 00192029043288: ADHESIVE, BRACKET-Tooth Conditioner, Resin
• 00192029043271: ADHESIVE, BRACKET-Tooth Conditioner, Resin