Click-It

GUDID 00192029007594

Upper Left Cuspids w/o Hooks 0° Torque, +8° Tip, 0.56 mm (.022"), Bondable

TP ORTHODONTICS INC

Orthodontic bracket, ceramic

• Primary Device ID: 00192029007594
• NIH Device Record Key: 7b9d1a37-7db5-447e-a776-e7be382905d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Click-It
• Version Model Number: 299-021
• 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	00192029007594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111234

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 [Click-It]

• 00192029007723: Test Item Box of 10 for Ind Item 299-075
• 00192029007716: Lower Right 2nd Bicuspid w/o Hooks -17° Torque, 0° Tip, 0.56 mm (.022"), Bondable
• 00192029007709: Lower Left 2nd Bicuspid w/o Hooks -17° Torque, 0° Tip, 0.56 mm (.022"), Bondable
• 00192029007693: Lower Right 1st Bicuspid w/o Hooks -12° Torque, 0° Tip, 0.56 mm (.022"), Bondable
• 00192029007686: Lower Left 1st Bicuspid w/o Hooks -12° Torque, 0° Tip, 0.56 mm (.022"), Bondable
• 00192029007679: Lower Right Cuspids w/ Distal Hooks0° Torque, +3° Tip, 0.56 mm (.022"), Bondable
• 00192029007662: Lower Left Cuspids w/ Distal Hooks 0° Torque, +3° Tip, 0.56 mm (.022"), Bondable
• 00192029007655: Lower Right Cuspids w/o Hooks 0° Torque, +3° Tip, 0.56 mm (.022"), Bondable
• 00192029007648: Lower Left Cuspids w/o Hooks 0° Torque, +3° Tip, 0.56 mm (.022"), Bondable
• 00192029007631: Lower Universal Anteriors Narrow -6° Torque, 0° Tip, 0.56 mm (.022") Bondable
• 00192029007624: Upper Universal Bicuspids w/o Hooks-7° Torque, 0° Tip, 0.56 mm (.022"), Bondable
• 00192029007617: Upper Right Cuspids w/ Distal Hooks0° Torque, +8° Tip, 0.56 mm (.022"), Bondable
• 00192029007600: Upper Left Cuspids w/ Distal Hooks 0° Torque, +8° Tip, 0.56 mm (.022"), Bondable
• 00192029007594: Upper Left Cuspids w/o Hooks 0° Torque, +8° Tip, 0.56 mm (.022"), Bondable
• 00192029007587: Upper Left Cuspids w/o Hooks 0° Torque, +8° Tip, 0.56 mm (.022"), Bondable
• 00192029007570: Upper Right Laterals +10° Torque, +8° Tip, 0.56 mm (.022"), Bondable
• 00192029007563: Upper Left Laterals +10° Torque, +8° Tip, 0.56 mm (.022"), Bondable
• 00192029007556: Upper Right Centrals +17° Torque, +4° Tip, 0.56 mm (.022"), Bondable
• 00192029007549: Upper Left Centrals +17° Torque, +4° Tip, 0.56 mm (.022"), Bondable
• 00192029007532: Upper & Lower 5-5 Cuspids w/o Hks, 0.56 mm (.022")
• 00192029007525: Upper & Lower 5-5 Cuspids w/ Hks, 0.56 mm (.022")
• 00192029007518: Upper 5-5 Cuspids w/o Hooks, 0.56 mm (.022")
• 00192029007501: Upper 5-5 Cuspids w/ Hooks, 0.56 mm (.022")