Carriere® SLX 3D™

GUDID 00190707057916

Carriere® SLX 3D™ Clear .022 UR3 HK +7T 9A 0O (RP)

ORTHO ORGANIZERS, INC.

Self-ligating orthodontic bracket

• Primary Device ID: 00190707057916
• NIH Device Record Key: 6790ce4f-431e-4ffc-899b-ddb3795f9871
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carriere® SLX 3D™
• Version Model Number: 776-UR3H-HK-RP
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190707057916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173440

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: 2019-03-22
• Device Publish Date: 2019-03-14

On-Brand Devices [Carriere® SLX 3D™]

• 00190707055851: Carriere® SLX 3D™ U-Clear L-M .022 Kit U/L 5x5 HKS
• 00190707055844: Carriere® SLX 3D™ .022 Kit U/L 5x5 HKS
• 00190707055578: Carriere® SLX 3D™ .022 Kit U/L 5x5 High-Low Torque HKS
• 00190707055561: Carriere® SLX 3D™ .022 Kit U/L 5x5 High-Low Torque HK
• 00190707055554: Carriere® SLX 3D™ Clear .022 Kit U/L 5x5 High-Low Torque HKS
• 00190707055547: Carriere® SLX 3D™ Clear .022 Kit U/L 5x5 High-Low Torque HK
• 00190707055431: Carriere® SLX 3D™ U-Clear L-M .022 Kit U/L 5x5 HKS
• 00190707054977: Carriere® SLX 3D™ Clear-L45 M .022 Kit U/L 5x5 HKS
• 00190707048594: Carriere® SLX 3D™ .022 Kit U/L 6x6 HKS
• 00190707048587: Carriere® SLX 3D™ .022 Kit U/L 6x6 HK
• 00190707048570: Carriere® SLX 3D™ .022 Kit U/L 5x5 HKS
• 00190707048563: Carriere® SLX 3D™ .022 Kit U/L 5x5 HK
• 00190707048556: Carriere® SLX 3D™ Clear .022 Kit U/L 6x6 HKS
• 00190707048549: Carriere® SLX 3D™ Clear .022 Kit U/L 6x6 HK
• 00190707048532: Carriere® SLX 3D™ Clear .022 Kit U/L 5x5 HKS
• 00190707048525: Carriere® SLX 3D™ Clear .022 Kit U/L 5x5 HK
• 00190707048518: Carriere® SLX 3D™ .022 UR7 NC Std -14T 0A 10DO
• 00190707048501: Carriere® SLX 3D™ .022 UL7 NC Std -14T 0A 10DO
• 00190707048495: Carriere® SLX 3D™ .022 LR7 NC Std -10T 0A 0O
• 00190707048488: Carriere® SLX 3D™ .022 LL7 NC Std -10T 0A 0O
• 00190707048471: Carriere® SLX 3D™ .022 UR6 HK -14T 0A 12DO
• 00190707048464: Carriere® SLX 3D™ .022 UR4/5 HK -7T 0A 0O
• 00190707048457: Carriere® SLX 3D™ .022 UR3 HK 0T 9A 0O
• 00190707048440: Carriere® SLX 3D™ .022 UR3 HK +7T 9A 0O
• 00190707048433: Carriere® SLX 3D™ .022 UR2 +12T 8A 0O
• 00190707048426: Carriere® SLX 3D™ .022 UR2 +8T 8A 0O
• 00190707048419: Carriere® SLX 3D™ .022 UR1 +17T 5A 0O
• 00190707048402: Carriere® SLX 3D™ .022 UR1 +12T 5A 0O
• 00190707048396: Carriere® SLX 3D™ .022 UL6 HK -14T 0A 12DO
• 00190707048389: Carriere® SLX 3D™ .022 UL4/5 HK -7T 0A 0O
• 00190707048372: Carriere® SLX 3D™ .022 U4/5 -7T 0A 0O
• 00190707048365: Carriere® SLX 3D™ .022 UL3 HK 0T 9A 0O
• 00190707048358: Carriere® SLX 3D™ .022 UL3 HK +7T 9A 0O
• 00190707048341: Carriere® SLX 3D™ .022 UL2 +12T 8A 0O
• 00190707048334: Carriere® SLX 3D™ .022 UL2 +8T 8A 0O
• 00190707048327: Carriere® SLX 3D™ .022 UL1 +17T 5A 0O
• 00190707048310: Carriere® SLX 3D™ .022 UL1 +12T 5A 0O
• 00190707048303: Carriere® SLX 3D™ .022 LR6 HK -25T 0A 2DO
• 00190707048297: Carriere® SLX 3D™ .022 LR5 HK -17T 2A 0O
• 00190707048280: Carriere® SLX 3D™ .022 LR5 -17T 2A 0O
• 00190707048273: Carriere® SLX 3D™ .022 LR4 HK -12T 2A 0O
• 00190707048266: Carriere® SLX 3D™ .022 LR4 -12T 2A 0O
• 00190707048259: Carriere® SLX 3D™ .022 LR3 HK -6T 5A 0O
• 00190707048242: Carriere® SLX 3D™ .022 LR3 HK 0T 5A 0O
• 00190707048235: Carriere® SLX 3D™ .022 LL6 HK -25T 0A 2DO
• 00190707048228: Carriere® SLX 3D™ .022 LL5 HK -17T 2A 0O
• 00190707048211: Carriere® SLX 3D™ .022 LL5 -17T 2A 0O
• 00190707048204: Carriere® SLX 3D™ .022 LL4 HK -12T 2A 0O
• 00190707048198: Carriere® SLX 3D™ .022 LL4 -12T 2A 0O
• 00190707048181: Carriere® SLX 3D™ .022 LL3 HK -6T 5A 0O