Bicuspid Laminated Mesh

GUDID 00192029049594

Bonding Base

TP ORTHODONTICS INC

Orthodontic bracket, metal

• Primary Device ID: 00192029049594
• NIH Device Record Key: ea155108-7e0f-434a-bfcc-c05f7a1fd09d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bicuspid Laminated Mesh
• Version Model Number: 210-366
• 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: 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029049594 [Primary]

FDA Product Code

• EJF: BRACKET, METAL, ORTHODONTIC

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: 2022-05-17
• Device Publish Date: 2022-05-09

Devices Manufactured by TP ORTHODONTICS INC

• 00192029050538 - Tip-Edge PLUS Stainless Steel Brackets: 2025-02-12 UL CEN Torque +12, Tip +5
• 00192029050545 - Tip-Edge PLUS Stainless Steel Brackets: 2025-02-12 UR CEN Torque +12, Tip +5
• 00192029050552 - Tip-Edge PLUS Stainless Steel Brackets: 2025-02-12 UL LAT Torque +8, Tip +9
• 00192029050569 - Tip-Edge PLUS Stainless Steel Brackets: 2025-02-12 UR LAT Torque +8, Tip +9
• 00192029050576 - Tip-Edge PLUS Stainless Steel Brackets: 2025-02-12 UL CUS Torque -4, Tip +11
• 00192029050583 - Tip-Edge PLUS Stainless Steel Brackets: 2025-02-12 UR CUS Torque -4, Tip +11
• 00192029050590 - Tip-Edge PLUS Stainless Steel Brackets: 2025-02-12 UP BI CCW Torque -7, Tip 0
• 00192029050606 - Tip-Edge PLUS Stainless Steel Brackets: 2025-02-12 UP BI CW Torque -7, Tip 0