Pre-Finisher Introductory Kit

GUDID 00192029041406

Non-Extraction

TP ORTHODONTICS INC

Orthodontic retainer

• Primary Device ID: 00192029041406
• NIH Device Record Key: 5dc7c7f3-6ab5-41a2-967b-40122b23af05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pre-Finisher Introductory Kit
• Version Model Number: 190-010
• 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	00192029041406 [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