InVu Ceramic Brackets

GUDID 00192029002353

Upper Right Cuspid Without Hook -7 Torque, +8 Tip Without Vertical Slot, Bondable 0.46mm (.018")

TP ORTHODONTICS INC

Orthodontic bracket, ceramic

• Primary Device ID: 00192029002353
• NIH Device Record Key: b3510d46-d9a4-4e16-ba18-ff5c38099c56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InVu Ceramic Brackets
• Version Model Number: 297-219
• 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	00192029002353 [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: 2019-02-20

On-Brand Devices [InVu Ceramic Brackets]

• 00192029006306: INVU STANDARD UPPER/ LOWER 5-5 .022KIT OR
• 00192029006290: INVU STANDARD UPPER/ LOWER 5-5 .018KIT OR
• 00192029006283: INVU STANDARD UPPER 5-5 .022 KIT
• 00192029006276: INVU STANDARD UPPER 5-5 .018 KIT
• 00192029006269: INVU STANDARD UPPER 3-3 .022 KIT
• 00192029006252: INVU STANDARD UPPER 3-3 .018 KIT
• 00192029006245: .022" LOWER LEFT/RIGHT BICUSPID W/O HOOK 0 TORQUE, 0 TIP BONDABLE
• 00192029006238: .018" LOWER LEFT/RIGHT BICUSPID W/O HOOK 0 TORQUE, 0 TIP BONDABLE
• 00192029006221: .022" UPPER LEFT/RIGHT BICUSPID W/O HOOK 0 TORQUE, 0 TIP BONDABLE
• 00192029006214: .018" UPPER LEFT/RIGHT BICUSPID W/O HOOK 0 TORQUE, 0 TIP BONDABLE
• 00192029006207: .022" LOWER LEFT/RIGHT ANTERIORS 0 TORQUE, 0 TIP BONDABLE
• 00192029006191: .018" LOWER LEFT/RIGHT ANTERIORS 0 TORQUE, 0 TIP BONDABLE
• 00192029006184: .022" UPPER/LOWER & LEFT/RIGHT CUSPID 0 TORQUE, 0 TIP BONDABLE
• 00192029006177: .018" UPPER/LOWER & LEFT/RIGHT CUSPID 0 TORQUE, 0 TIP BONDABLE
• 00192029006160: .022" UPPER LEFT/RIGHT LATERAL 0 TORQUE, 0 TIP BONDABLE
• 00192029006153: .018" UPPER LEFT/RIGHT LATERAL 0 TORQUE, 0 TIP BONDABLE
• 00192029006146: .022" UPPER LEFT/RIGHT CENTRAL 0 TORQUE, 0 TIP BONDABLE
• 00192029006139: .018" UPPER LEFT/RIGHT CENTRAL 0 TORQUE, 0 TIP BONDABLE
• 00192029005590: Lower Right Cuspid With Hook 0 Torque, +3 Tip 0.56mm (.022")
• 00192029005552: Lower Left Cuspid With Hook 0 Torque, +3 Tip 0.56mm (.022")
• 00192029005514: Lower Right Cuspid With Hook 0 Torque, +3 Tip 0.46mm (.018")
• 00192029005477: Lower Left Cuspid With Hook 0 Torque, +3 Tip 0.46mm (.018")
• 00192029005439: Lower Right Cuspid With Hook -11 Torque, +6 Tip Without Vertical Slot, Bondable 0.56mm (.022")
• 00192029005392: Lower Left Cuspid With Hook -11 Torque, +6 Tip Without Vertical Slot, Bondable 0.56mm (.022")
• 00192029005354: Lower Right Cuspid With Hook -11 Torque, +6 Tip Without Vertical Slot, Bondable 0.46mm (.018")
• 00192029005316: Lower Left Cuspid With Hook -11 Torque, +6 Tip Without Vertical Slot, Bondable 0.46mm (.018")
• 00192029005279: Upper Right Cuspid With Hook 0 Torque, +8 Tip Without Vertical Slot 0.56mm (.022")
• 00192029005231: Upper Left Cuspid With Hook 0 Torque, +8 Tip Without Vertical Slot 0.56mm (.022")
• 00192029005194: Upper Right Cuspid With Hook 0 Torque, +8 Tip Without Vertical Slot 0.46mm (.018")
• 00192029005156: Upper Left Cuspid With Hook 0 Torque, +8 Tip Without Vertical Slot 0.46mm (.018")
• 00192029005118: Upper & Lower 5-5 With Cuspid/Bicuspid Hooks 0.56mm (.022")
• 00192029005071: Upper & Lower 5-5 With Cuspid/Bicuspid Hooks 0.46mm (.018")
• 00192029005033: Upper 5-5 With Cuspid/Bicuspid Hooks 0.56mm (.022")
• 00192029004999: Upper 5-5 With Cuspid/Bicuspid Hooks 0.46mm (.018")
• 00192029004951: Upper & Lower 5-5 Cuspid/Bicuspid With Hooks 0.56mm (.022")
• 00192029004913: Upper & Lower 5-5 Cuspid/Bicuspid With Hooks 0.46mm (.018")
• 00192029004876: Upper 5-5 Cuspid/Bicuspid With Hooks 0.56mm (.022")
• 00192029004838: Upper 5-5 Cuspid/Bicuspid With Hooks 0.46mm (.018")
• 00192029004814: Cuspid/Bicuspid With Hooks Upper & Lower 5-5 0.56mm (.022")
• 00192029004791: Cuspid/Bicuspid With Hooks Upper & Lower 5-5 0.46mm (.018")
• 00192029004777: Cuspid/Bicuspid With Hooks Upper 5-5 0.56mm (.022")
• 00192029004753: Cuspid/Bicuspid With Hooks Upper 5-5 0.46mm (.018")
• 00192029004746: Upper 5-5 Without Hooks 0.56mm (.022")
• 00192029004722: Upper 5-5 Without Hooks 0.56mm (.022")
• 00192029004715: Upper 5-5 Without Hooks 0.46mm (.018")
• 00192029004692: Upper 5-5 With Cuspid Hooks 0.46mm (.018")
• 00192029004685: Upper 3-3 Without Hooks 0.56mm (.022")
• 00192029004678: Upper 3-3 Without Hooks 0.46mm (.018")
• 00192029004593: Lower Right Cuspid Wo/Hook -6 Torque, +3 Tip 0.56mm (.022")
• 00192029004579: Lower Left Cuspid Wo/Hook -6 Torque, +3 Tip 0.56mm (.022")