Bonding Accessories

GUDID 00192029000212

Enamel Conditioner S

TP ORTHODONTICS INC

Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive

• Primary Device ID: 00192029000212
• NIH Device Record Key: 6789b336-4812-4d20-9b49-25c9e0f09ce0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bonding Accessories
• Version Model Number: 150-020
• 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: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com
• Phone: +1(219)785-2591
• Email: matt.oswald@tportho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029000212 [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