Bicuspid Laminated Mesh

GUDID 00192029049594

Bonding Base

TP ORTHODONTICS INC

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal 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

• 00192029050491 - Cuspid Laminated Mesh: 2024-01-05 MISC. BRACKETS
• 00192029043264 - Foam Pellets: 2023-10-13 ADHESIVE, BRACKET-Tooth Conditioner, Resin
• 00192029043271 - Bonding Accessories: 2023-10-13 ADHESIVE, BRACKET-Tooth Conditioner, Resin
• 00192029043288 - Bonding Accessories: 2023-10-13 ADHESIVE, BRACKET-Tooth Conditioner, Resin
• 00192029017494 - Tip-Edge SL PLUS Stainless Steel Brackets: 2022-10-25 SL PLUS NON EXT 22 KIT
• 00192029017500 - Tip-Edge SL PLUS Stainless Steel Brackets: 2022-10-25 SL PLUS NON EXT 22 KIT OR
• 00192029017517 - Tip-Edge SL PLUS Stainless Steel Brackets: 2022-10-25 SL TE PLUS UL CEN 22
• 00192029017524 - Tip-Edge SL PLUS Stainless Steel Brackets: 2022-10-25 SL TE PLUS UR CEN 22