InVu Readi-Base Bracket

GUDID 00192029000519

Upper 5-5 Cuspid With Hooks 0.56mm (.022")

TP ORTHODONTICS INC

Orthodontic bracket, ceramic

• Primary Device ID: 00192029000519
• NIH Device Record Key: c284a5fd-0b8d-4061-a297-33ed851c1b69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InVu Readi-Base Bracket
• Version Model Number: 297-065RBX
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029000519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950992

FDA Product Code

• NJM: Bracket, ceramic, 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: 2019-03-11
• Device Publish Date: 2019-02-26

On-Brand Devices [InVu Readi-Base Bracket]

• 00192029001622: Lower Left/Right Anteriors -1 Torque, 0 Tip, 0.56 mm (.022") Without Vertical Slot, Bondabl
• 00192029000557: Upper 5-5 Cuspid With Hooks 0.56mm (.022")
• 00192029000533: Upper & Lower 5-5 Cuspid With Hooks 0.46mm (.018")
• 00192029000519: Upper 5-5 Cuspid With Hooks 0.56mm (.022")
• 00192029000496: Upper 5-5 Cuspid With Hooks 0.46mm (.018")