Resolve Ceramic CRU118L

GUDID D746CRU118L1

Roth Prescription Maxillary Arch Central .018” Slot Ceramic Aesthetic Bracket

RAINTREE ESSIX INC.

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• Primary Device ID: D746CRU118L1
• NIH Device Record Key: c8b2c8fe-2155-4159-af7f-3b8be6ffa9ee
• Commercial Distribution Discontinuation: 2021-02-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Resolve Ceramic
• Version Model Number: CRU118L
• Catalog Number: CRU118L
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D746CRU118L1 [Primary]

FDA Product Code

• EJF: BRACKET, METAL, ORTHODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-09-23
• Device Publish Date: 2016-09-24

On-Brand Devices [Resolve Ceramic]

• D746FSU2181: Standard Edgewise Upper Lateral .018” Slot Crystal Clear Composite Bracket
• D746FS3181: Standard Edgewise Cuspids .018” Slot Crystal Clear Composite Bracket
• D746FS18BI1: Standard Edgewise Bicuspids .018” Slot Crystal Clear Composite Bracket
• D746FRU22BIHK1: Roth Prescription Maxillary Arch Bicuspid with Hook .022”
• D746FRL4221: Roth Prescription Mandibular Arch Lower 1st Bicuspid no Hook .022”
• D746FRL4181: Roth Prescription Mandibular Arch Lower 1st Bicuspid no Hook .018”
• D746FRL322RHK1: Roth Prescription Mandibular Arch Lower Cuspid with Hook .022”
• D746CSU2181: Standard Edgewise Lower Lateral .018” Slot Ceramic Aesthetic Bracket
• D746CSU1181: Standard Edgewise Upper Central .018” Slot Ceramic Aesthetic Bracket
• D746CSL1181: Standard Edgewise Lower Anteriors .018” Slot Ceramic Aesthetic Bracket
• D746CRU322RHK1: Roth Prescription Maxillary Arch Cuspid with Hook .022”
• D746CRU318R1: Roth Prescription Maxillary Arch Cuspid .018” Slot Ceramic Aesthetic Bracket
• D746CRU222R1: Roth Prescription Maxillary Arch Lateral .022” Slot Ceramic Aesthetic Bracket
• D746CRU222L1: Roth Prescription Maxillary Arch Lateral .022” Slot Ceramic Aesthetic Bracket
• D746CRL5221: Roth Prescription Mandibular Arch 2nd Bicuspid .022”
• D746CRL4221: Roth Prescription Mandibular Arch 1st Bicuspid .022”
• D746CRL4181: Roth Prescription Mandibular Arch 1st Bicuspid .018”
• D746CRL322RHK1: Roth Prescription Mandibular Arch Cuspid with Hook .022”
• D746CRL318R1: Roth Prescription Mandibular Arch Cuspid .018” Slot Ceramic Aesthetic Bracket
• D746FSU2221: Standard Edgewise Upper Lateral .022” Slot Crystal Clear Composite Bracket
• D746FSU1221: Standard Edgewise Upper Central .022” Slot Crystal Clear Composite Bracket
• D746FSU1181: Standard Edgewise Upper Central .018 Slot Crystal Clear Composite Bracket
• D746FSL1221: Standard Edgewise Lower Anteriors .022” Slot Crystal Clear Composite Bracket
• D746FSL1181: Standard Edgewise Lower Anteriors .018” Slot Crystal Clear Composite Bracket
• D746FS3221: Standard Edgewise Cuspids .022” Slot Crystal Clear Composite Bracket
• D746FS22BI1: Standard Edgewise Bicuspids .022” Slot Crystal Clear Composite Bracket
• D746FRU322RHK1: Roth Prescription Maxillary Arch Cuspid with Hook .022”
• D746FRU322R1: Roth Prescription Maxillary Arch Cuspid no Hook .022”
• D746FRU322LHK1: Roth Prescription Maxillary Arch Cuspid with Hook .022”
• D746FRU322L1: Roth Prescription Maxillary Arch Cuspid no Hook .022”
• D746FRU318RHK1: Roth Prescription Maxillary Arch Cuspid with Hook .018”
• D746FRU318R1: Roth Prescription Maxillary Arch Cuspid no Hook .018”
• D746FRU318LHK1: Roth Prescription Maxillary Arch Cuspid with Hook .018”
• D746FRU318L1: Roth Prescription Maxillary Arch Cuspid no Hook .018”
• D746FRU22BI1: Roth Prescription Maxillary Arch Bicuspid no Hook .022”
• D746FRU222R1: Roth Prescription Maxillary Arch Lateral .022”
• D746FRU222L1: Roth Prescription Maxillary Arch Lateral .022”
• D746FRU218R1: Roth Prescription Maxillary Arch Lateral .018”
• D746FRU218L1: Roth Prescription Maxillary Arch Lateral .018”
• D746FRU18BIHK1: Roth Prescription Maxillary Arch Bicuspid with Hook .018”
• D746FRU18BI1: Roth Prescription Maxillary Arch Bicuspid no Hook .018”
• D746FRU122R1: Roth Prescription Maxillary Arch Central .022”
• D746FRU122L1: Roth Prescription Maxillary Arch Central .022”
• D746FRU118R1: Roth Prescription Maxillary Arch Central .018”
• D746FRU118L1: Roth Prescription Maxillary Arch Central .018”
• D746FRL5221: Roth Prescription Mandibular Arch Lower 2nd Bicuspid no Hook .022”
• D746FRL518HK1: Roth Prescription Mandibular Arch Lower 2nd Bicuspid with Hook .018”
• D746FRL5181: Roth Prescription Mandibular Arch Lower 2nd Bicuspid no Hook .018”
• D746FRL422HK1: Roth Prescription Mandibular Arch Lower 1st Bicuspid with Hook .022”
• D746FRL418HK1: Roth Prescription Mandibular Arch Lower 1st Bicuspid with Hook .018”