MXi Straight-Edge Bracket

GUDID 00192029006412

.022" UPPER LEFT/RIGHT UNIVERSAL BICUSPID -7 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT

TP ORTHODONTICS INC

Orthodontic bracket, ceramic

• Primary Device ID: 00192029006412
• NIH Device Record Key: 6742cbea-9030-4ca1-923e-eb9696020924
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MXi Straight-Edge Bracket
• Version Model Number: 298-551F
• 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	00192029006412 [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 Straight-Edge Bracket]

• 00192029006429: .022" LOWER LEFT/RIGHT UNIVERSAL BICUSPID -20 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006412: .022" UPPER LEFT/RIGHT UNIVERSAL BICUSPID -7 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006405: .022" UPPER RIGHT CUSPID -2 TORQUE, +11 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006399: .022" UPPER LEFT CUSPID -2 TORQUE, +11 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006382: .022" UPPER RIGHT CENTRAL +12 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006375: .022" UPPER LEFT CENTRAL +12 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLOT
• 00192029006368: .022" LOWER RIGHT CUSPID -11 TORQUE, +5 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006351: .022" LOWER LEFT CUSPID -11 TORQUE, +5 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006344: .022" LOWER LEFT/RIGHT UNIVERSAL ANTERIOR -1 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006337: .022" UPPER RIGHT LATERAL +8 TORQUE, +9 TIP, 4 MM WITH VERTICAL SLOT
• 00192029006320: Upper Left Lateral with Vertical Slot +8 Torque, +9 Tip Oriented, 4 mm, Red 0.56 mm (.022")
• 00192029006313: CUSPIDS BRACKETS KIT .022" ROTH RX WITH LONGER JIGS