TipEdge PLUS Ceramic Readi-Base Bracket

GUDID 00192029005804

.022" UPPER BICUSPID - CW 3.5 MM, PURPLE I.D. -7 TORQUE, 0 TIP

TP ORTHODONTICS INC

Orthodontic bracket, ceramic

• Primary Device ID: 00192029005804
• NIH Device Record Key: c6f53c06-f851-422e-a33c-7efd8c987a33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TipEdge PLUS Ceramic Readi-Base Bracket
• Version Model Number: 297-632
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029005804 [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: 2019-02-12

On-Brand Devices [TipEdge PLUS Ceramic Readi-Base Bracket]

• 00192029005859: Upper Left Central +12 Torque, +5 Tip Oriented, 4 mm, Red 0.56 mm (.022")
• 00192029005842: .022" LOWER BICUSPID - CW 3.5 MM, PURPLE I.D. -20 TORQUE, 0 TIP
• 00192029005835: .022" LOWER BICUSPID - CCW 3.5 MM, PURPLE I.D. -20 TORQUE, 0 TIP
• 00192029005828: .022" LOWER RIGHT ANTERIOR 3.5 MM, RED I.D. -1 TORQUE, 0 TIP
• 00192029005811: .022" LOWER LEFT ANTERIOR 3.5 MM, RED I.D. -1 TORQUE, 0 TIP
• 00192029005804: .022" UPPER BICUSPID - CW 3.5 MM, PURPLE I.D. -7 TORQUE, 0 TIP
• 00192029005798: .022" UPPER BICUSPID - CCW 3.5 MM, PURPLE I.D. -7 TORQUE, 0 TIP
• 00192029005781: .022" UPPER RIGHT LATERAL 3.5 MM, GREEN I.D. +8 TORQUE, +9 TIP
• 00192029005774: .022" UPPER LEFT LATERAL 3.5 MM, GREEN I.D. +8 TORQUE, +9 TIP
• 00192029005767: UPPER 5-5 CERAMIC, LOWER 5-5 METAL NON-EXTRACTION, WITH JIG .022" ARCHWIRE SLOT
• 00192029005750: UPPER 5-5 CERAMIC, LOWER 5-5 METAL NON-EXTRACTION, WITHOUT JIG .022" ARCHWIRE SLOT
• 00192029005743: UPPER 3-3 CERAMIC & 4-5 METAL LOWER 5-5 METAL, NON-EXTRACTION .022" ARCHWIRE SLOT, WITH
• 00192029005736: UPPER 3-3 CERAMIC & 4-5 METAL LOWER 5-5 METAL, NON-EXTRACTION .022" ARCHWIRE SLOT, WITH
• 00192029005729: LOWER 5 TO 5 NON-EXTRACTION .022" ARCHWIRE SLOT WITH JIGS
• 00192029005712: LOWER 3 TO 3 .022" ARCHWIRE SLOT WITH JIGS
• 00192029005705: UPPER & LOWER 5 TO 5 NON-EXTRACTION .022" ARCHWIRE SLOT WITH JIGS
• 00192029005699: UPPER 5 TO 5 NON-EXTRACTION .022" ARCHWIRE SLOT WITH JIGS
• 00192029005675: UPPER 3 TO 3 .022" ARCHWIRE SLOT WITH JIGS
• 00192029002681: UPPER & LOWER 3 TO 3 .022" ARCHWIRE SLOT WITH JIGS