TipEdge PLUS Ceramic Readi-Base Brackets

GUDID 00192029006894

.022" UPPER BICUSPID-CCW

TP ORTHODONTICS INC

Orthodontic bracket, ceramic

• Primary Device ID: 00192029006894
• NIH Device Record Key: 3c868e69-5305-43d5-a698-0ec355f2c2ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TipEdge PLUS Ceramic Readi-Base Brackets
• Version Model Number: RB297-645
• 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	00192029006894 [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: 2019-02-08

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

• 00192029006962: .022" UPPER RIGHT CUSPID
• 00192029006955: .022" UPPER LEFT CUSPID
• 00192029006948: .022" LOWER BICUSPID-CW
• 00192029006931: .022" LOWER BICUSPID-CCW
• 00192029006924: .022" LOWER RIGHT CUSPID
• 00192029006917: .022" LOWER LEFT CUSPID
• 00192029006900: .022" UPPER BICUSPID-CW
• 00192029006894: .022" UPPER BICUSPID-CCW
• 00192029006887: .022" UPPER RIGHT CENTRAL
• 00192029006870: .022" UPPER LEFT CENTRAL
• 00192029006863: .022" LOWER RIGHT ANTERIOR
• 00192029006856: .022" LOWER LEFT ANTERIOR
• 00192029006849: .022" UPPER RIGHT LATERAL
• 00192029006832: .022" UPPER LEFT LATERAL
• 00192029006825: READI-BASE TIP-EDGE PLUS CERAMIC UPPER/LOWER 5-5 .022 KIT OR