Pre-Finisher

GUDID 00192029041550

Non-Extraction

TP ORTHODONTICS INC

Orthodontic retainer

• Primary Device ID: 00192029041550
• NIH Device Record Key: f3c18d85-bceb-407d-a5a6-62258efb807b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pre-Finisher
• Version Model Number: 190-053
• 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	00192029041550 [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]

• 00192029042632: Asian Non-Extraction
• 00192029042625: Asian Non-Extraction
• 00192029042618: Asian Non-Extraction
• 00192029042601: Asian Non-Extraction
• 00192029042595: Asian Non-Extraction
• 00192029042588: Asian Non-Extraction
• 00192029042571: Asian Non-Extraction
• 00192029042564: Asian Non-Extraction
• 00192029042557: Asian 4 Bicuspid Extraction
• 00192029042540: Asian 4 Bicuspid Extraction
• 00192029042533: Asian 4 Bicuspid Extraction
• 00192029042526: Asian 4 Bicuspid Extraction
• 00192029042519: Asian 4 Bicuspid Extraction
• 00192029042502: Asian 4 Bicuspid Extraction
• 00192029042496: Asian 4 Bicuspid Extraction
• 00192029042489: Asian 4 Bicuspid Extraction
• 00192029042472: Asian 4 Bicuspid Extraction
• 00192029042465: Asian 4 Bicuspid Extraction
• 00192029042458: Asian 4 Bicuspid Extraction
• 00192029042441: Asian 4 Bicuspid Extraction
• 00192029042434: Asian 4 Bicuspid Extraction
• 00192029042427: Asian 4 Bicuspid Extraction
• 00192029042410: 4 Bicuspid Extraction w/Seating Springs
• 00192029042403: 4 Bicuspid Extraction w/Seating Springs
• 00192029042397: 4 Bicuspid Extraction w/Seating Springs
• 00192029042380: 4 Bicuspid Extraction w/Seating Springs
• 00192029042373: 4 Bicuspid Extraction w/Seating Springs
• 00192029042366: 4 Bicuspid Extraction w/Seating Springs
• 00192029042359: 4 Bicuspid Extraction w/Seating Springs
• 00192029042342: 4 Bicuspid Extraction w/Seating Springs
• 00192029042335: 4 Bicuspid Extraction w/Seating Springs
• 00192029042328: 4 Bicuspid Extraction w/Seating Springs
• 00192029042311: 4 Bicuspid Extraction w/Seating Springs
• 00192029042304: 4 Bicuspid Extraction w/Seating Springs
• 00192029042298: 4 Bicuspid Extraction w/Seating Springs
• 00192029042281: 4 Bicuspid Extraction w/Seating Springs
• 00192029042274: 4 Bicuspid Extraction w/Seating Springs
• 00192029042267: 4 Bicuspid Extraction w/Seating Springs
• 00192029042250: 4 Bicuspid Extraction w/Seating Springs
• 00192029042243: 4 Bicuspid Extraction
• 00192029042236: 4 Bicuspid Extraction
• 00192029042229: 4 Bicuspid Extraction
• 00192029042212: 4 Bicuspid Extraction
• 00192029042205: 4 Bicuspid Extraction
• 00192029042199: 4 Bicuspid Extraction
• 00192029042182: 4 Bicuspid Extraction
• 00192029042175: 4 Bicuspid Extraction
• 00192029042168: 4 Bicuspid Extraction
• 00192029042151: 4 Bicuspid Extraction
• 00192029042144: 4 Bicuspid Extraction