MXi Tip-Edge Brackets

GUDID 00192029006580

.022" UPPER RIGHT LATERAL +8 TORQUE, +9 TIP, 4 MM WITH VERTICAL SLOT

TP ORTHODONTICS INC

Orthodontic bracket, ceramic

• Primary Device ID: 00192029006580
• NIH Device Record Key: 10da8885-8b4f-4c61-b0e5-c347ed8653de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MXi Tip-Edge Brackets
• Version Model Number: 298-821F
• 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	00192029006580 [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: 2019-02-15

On-Brand Devices [MXi Tip-Edge Brackets]

• 00192029006818: .022" LOWER RIGHT CUSPID -11 TORQUE, +5 TIP, 5 MM WITH VERTICAL SLOT
• 00192029006801: .022" LOWER LEFT CUSPID -11 TORQUE, +5 TIP, 5 MM WITH VERTICAL SLOT
• 00192029006795: .022" UPPER LEFT CUSPID -2 TORQUE, +11 TIP, 5 MM WITH VERTICAL SLOT
• 00192029006788: .022" LOWER CW BICUSPID -20 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006771: .022" LOWER CCW BICUSPID -20 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006764: .022" LOWER RIGHT CUSPID -11 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006757: .022" LOWER LEFT CUSPID -11 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006740: .022" UPPER CW BICUSPID -7 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006733: .022" UPPER CCW BICUSPID -7 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006726: .022" UPPER RIGHT CUSPID -2 TORQUE, +11 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006719: .022" UPPER LEFT CUSPID -2 TORQUE, +11 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006702: .022" UPPER RIGHT CENTRAL +12 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLO
• 00192029006696: .022" UPPER LEFT CENTRAL +12 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006689: .022" LOWER CW BICUSPID -20 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006672: .022" LOWER CCW BICUSPID -20 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006665: .022" LOWER RIGHT CUSPID -11 TORQUE, +5 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006658: .022" LOWER LEFT CUSPID -11 TORQUE, +5 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006641: .022" LOWER RIGHT ANTERIOR -1 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006634: .022" LOWER LEFT ANTERIOR -1 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006627: .022" UPPER CW BICUSPID -7 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006610: .022" UPPER CCW BICUSPID -7 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006603: .022" UPPER RIGHT CUSPID -2 TORQUE, +11 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006597: .022" UPPER LEFT CUSPID -2 TORQUE, +11 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006580: .022" UPPER RIGHT LATERAL +8 TORQUE, +9 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006573: .022" UPPER LEFT LATERAL +8 TORQUE, +9 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006566: .022" UPPER RIGHT CENTRAL +12 TORQUE, +5 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006559: Upper Left Central with Vertical Slot +12 Torque, +5 Tip Oriented, 4 mm, Red 0.56 mm (.022")
• 00192029006542: .022" LOWER CW BICUSPID -20 TORQUE, 0 TIP, 3.5 MM WITH VERTICAL SLOT
• 00192029006535: .022" LOWER CCW BICUSPID -20 TORQUE, 0 TIP, 3.5 MM WITH VERTICAL SLOT
• 00192029006528: .022" LOWER RIGHT ANTERIOR -1 TORQUE, 0 TIP, 3.5 MM WITH VERTICAL SLOT
• 00192029006511: .022" LOWER LEFT ANTERIOR -1 TORQUE, 0 TIP, 3.5 MM WITH VERTICAL SLOT
• 00192029006504: .022" UPPER RIGHT LATERAL +8 TORQUE, +9 TIP, 3.5 MM WITH VERTICAL SLOT
• 00192029006498: .022" UPPER LEFT LATERAL +8 TORQUE, +9 TIP, 3.5 MM WITH VERTICAL SLOT
• 00192029006481: LOWER 5-5 NON-EXTRACTION KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
• 00192029006474: LOWER 3-3 KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
• 00192029006467: UPPER & LOWER 5-5 NON-EXTRACTION KIT .022" SLOT, WITH JIGS, WITH VERTICAL SLOT
• 00192029006450: UPPER & LOWER 3-3 KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
• 00192029006443: UPPER 5-5 NON-EXTRACTION KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
• 00192029006436: UPPER 3-3 KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT