Pre-Finisher Introductory Kit

GUDID 00192029041611

Non-Extraction w/Seating Springs

TP ORTHODONTICS INC

Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer

• Primary Device ID: 00192029041611
• NIH Device Record Key: ef9a599b-b007-4ca6-b836-66c7e1021442
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pre-Finisher Introductory Kit
• Version Model Number: 190-110
• Company DUNS: 005432299
• Company Name: TP ORTHODONTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029041611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780619

FDA Product Code

• KMY: POSITIONER, TOOTH, PREFORMED

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: 2021-02-23
• Device Publish Date: 2021-02-15

On-Brand Devices [Pre-Finisher Introductory Kit]

• 00192029041611: Non-Extraction w/Seating Springs
• 00192029041406: Non-Extraction