Comp Expansion Swivel Key

GUDID 00192029049631

Swivel Key

TP ORTHODONTICS INC

Orthodontic palate expander/teeth aligner, bonded

• Primary Device ID: 00192029049631
• NIH Device Record Key: c9049fb0-f906-4dbd-88cd-1cf51a3cfc73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comp Expansion Swivel Key
• Version Model Number: 610-087
• 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	00192029049631 [Primary]

FDA Product Code

• DZN: INSTRUMENTS, DENTAL HAND

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

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• 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