TipEdge Plus Ceramic Brackets

GUDID 00192029005989

.022" LOWER BICUSPID - CW 4.0 MM, PURPLE I.D. -20 TORQUE, 0 TIP

TP ORTHODONTICS INC

Orthodontic bracket, ceramic

• Primary Device ID: 00192029005989
• NIH Device Record Key: a4a6d883-8830-42fd-b27c-4b3d1532523d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TipEdge Plus Ceramic Brackets
• Version Model Number: 297-654
• 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	00192029005989 [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: 2019-02-13

On-Brand Devices [TipEdge Plus Ceramic Brackets]

• 00192029006122: .022" LOWER RIGHT CUSPID 5.0 MM, BLACK I.D. -11 TORQUE, +5 TIP
• 00192029006115: .022" LOWER LEFT CUSPID 5.0 MM, BLACK I.D. -11 TORQUE, +5 TIP
• 00192029006108: .022" UPPER RIGHT CUSPID 5.0 MM, BLACK I.D. -2 TORQUE, +11 TIP
• 00192029006092: .022" UPPER LEFT CUSPID 5.0 MM, BLACK I.D. -2 TORQUE, +11 TIP
• 00192029006085: .022" LOWER BICUSPID - CW 4.5 MM, PURPLE I.D. -20 TORQUE, 0 TIP
• 00192029006078: .022" LOWER BICUSPID - CCW 4.5 MM, PURPLE I.D. -20 TORQUE, 0 TIP
• 00192029006061: .022" LOWER RIGHT CUSPID 4.5 MM, BLACK I.D. -11 TORQUE, +5 TIP
• 00192029006054: .022" LOWER LEFT CUSPID 4.5 MM, BLACK I.D. -11 TORQUE, +5 TIP
• 00192029006047: .022" UPPER BICUSPID - CW 4.5 MM, PURPLE I.D. -7 TORQUE, 0 TIP
• 00192029006030: .022" UPPER BICUSPID - CCW 4.5 MM, PURPLE I.D. -7 TORQUE, 0 TIP
• 00192029006023: .022" UPPER RIGHT CUSPID 4.5 MM, BLACK I.D. -2 TORQUE, +11 TIP
• 00192029006016: .022" UPPER LEFT CUSPID 4.5 MM, BLACK I.D. -2 TORQUE, +11 TIP
• 00192029006009: .022" UPPER RIGHT CENTRAL 4.5 MM, RED I.D. +12 TORQUE, +5 TIP
• 00192029005996: .022" UPPER LEFT CENTRAL 4.5 MM, RED I.D. +12 TORQUE, +5 TIP
• 00192029005989: .022" LOWER BICUSPID - CW 4.0 MM, PURPLE I.D. -20 TORQUE, 0 TIP
• 00192029005972: .022" LOWER BICUSPID - CCW 4.0 MM, PURPLE I.D. -20 TORQUE, 0 TIP
• 00192029005965: .022" LOWER RIGHT CUSPID 4.0 MM, BLACK I.D. -11 TORQUE, +5 TIP
• 00192029005958: .022" LOWER LEFT CUSPID 4.0 MM, BLACK I.D. -11 TORQUE, +5 TIP
• 00192029005941: .022" LOWER RIGHT ANTERIOR 4.0 MM, RED I.D. -1 TORQUE, 0 TIP
• 00192029005934: .022" LOWER LEFT ANTERIOR 4.0 MM, RED I.D. -1 TORQUE, 0 TIP
• 00192029005927: .022" UPPER BICUSPID - CW 4.0 MM, PURPLE I.D. -7 TORQUE, 0 TIP
• 00192029005910: .022" UPPER BICUSPID - CCW 4.0 MM, PURPLE I.D. -7 TORQUE, 0 TIP
• 00192029005903: .022" UPPER RIGHT CUSPID 4.0 MM, BLACK I.D. -2 TORQUE, +11 TIP
• 00192029005897: .022" UPPER LEFT CUSPID 4.0 MM, BLACK I.D. -2 TORQUE, +11 TIP
• 00192029005880: .022" UPPER RIGHT LATERAL 4.0 MM, GREEN I.D. +8 TORQUE, +9 TIP
• 00192029005873: .022" UPPER LEFT LATERAL 4.0 MM, GREEN I.D. +8 TORQUE, +9 TIP
• 00192029005866: .022" UPPER RIGHT CENTRAL 4.0 MM, RED I.D. +12 TORQUE, +5 TIP