Ceramic/Metal Combination Kits

GUDID 00192029000397

0.56mm (.022") Upper 4-4 & Lower 3-3 InVu Ceramic Brackets WO/Cuspid Hook

TP ORTHODONTICS INC

Orthodontic bracket, ceramic

• Primary Device ID: 00192029000397
• NIH Device Record Key: 0bc96041-0f75-47bf-ac09-c13a4231241d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramic/Metal Combination Kits
• Version Model Number: 297-039
• 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	00192029000397 [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: 2019-02-22

On-Brand Devices [Ceramic/Metal Combination Kits]

• 00192029002056: INVU MBT UL 3-3, NU-EDGE 4-5, LOWERBI W/O HOOK 022 KIT
• 00192029000908: 0.56 mm (.022") Upper & Lower 3-3 InVu Ceramic
• 00192029000472: 0.56mm (.022)" Upper 4-4 & Lower 3-3 InVu Ceramic
• 00192029000458: 0.46mm (.018") Upper 4-4 & Lower 3-3 InVu Ceramic
• 00192029000441: 0.56mm (.022") Upper 5-5 InVu Ceramic
• 00192029000427: 0.46mm (.018") Upper 5-5 InVu Ceramic
• 00192029000410: 0.56mm (.022") Upper 3-3 InVu Ceramic
• 00192029000403: 0.46mm (.018") Upper 3-3 InVu Ceramic
• 00192029000397: 0.56mm (.022") Upper 4-4 & Lower 3-3 InVu Ceramic Brackets WO/Cuspid Hook
• 00192029000380: 0.56mm (.022") Upper 4-4 & Lower 3-3 InVu Ceramic Brackets W/Cuspid Hook
• 00192029000366: 0.46mm (.018)" Upper 4-4 & Lower 3-3 InVu Ceramic Brackets W/Cuspid Hook
• 00192029000359: 0.56mm (.022") Upper 5-5 InVu Ceramic Brackets
• 00192029000335: 0.46mm (.018") Upper 5-5 InVu Ceramic Brackets
• 00192029000328: 0.56mm (.022") Upper 3-3 InVu Ceramic Brackets
• 00192029000311: 0.46mm (.018") Upper 3-3 InVu Ceramic Brackets