Resolve Ceramic CRU218L

GUDID D746CRU218L1

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

RAINTREE ESSIX INC.

Orthodontic bracket, ceramic
Primary Device IDD746CRU218L1
NIH Device Record Key9fa4df09-f3dc-4dc5-8a32-6e19d2ec7991
Commercial Distribution Discontinuation2021-02-18
Commercial Distribution StatusNot in Commercial Distribution
Brand NameResolve Ceramic
Version Model NumberCRU218L
Catalog NumberCRU218L
Company DUNS801157132
Company NameRAINTREE ESSIX INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD746CRU218L1 [Primary]

FDA Product Code

EJFBRACKET, METAL, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-02-19
Device Publish Date2016-09-24

On-Brand Devices [Resolve Ceramic]

D746FSU2181Standard Edgewise Upper Lateral .018” Slot Crystal Clear Composite Bracket
D746FS3181Standard Edgewise Cuspids .018” Slot Crystal Clear Composite Bracket
D746FS18BI1Standard Edgewise Bicuspids .018” Slot Crystal Clear Composite Bracket
D746FRU22BIHK1Roth Prescription Maxillary Arch Bicuspid with Hook .022”
D746FRL4221Roth Prescription Mandibular Arch Lower 1st Bicuspid no Hook .022”
D746FRL4181Roth Prescription Mandibular Arch Lower 1st Bicuspid no Hook .018”
D746FRL322RHK1Roth Prescription Mandibular Arch Lower Cuspid with Hook .022”
D746CSU2181Standard Edgewise Lower Lateral .018” Slot Ceramic Aesthetic Bracket
D746CSU1181Standard Edgewise Upper Central .018” Slot Ceramic Aesthetic Bracket
D746CSL1181Standard Edgewise Lower Anteriors .018” Slot Ceramic Aesthetic Bracket
D746CRU322RHK1Roth Prescription Maxillary Arch Cuspid with Hook .022”
D746CRU318R1Roth Prescription Maxillary Arch Cuspid .018” Slot Ceramic Aesthetic Bracket
D746CRU222R1Roth Prescription Maxillary Arch Lateral .022” Slot Ceramic Aesthetic Bracket
D746CRU222L1Roth Prescription Maxillary Arch Lateral .022” Slot Ceramic Aesthetic Bracket
D746CRL5221Roth Prescription Mandibular Arch 2nd Bicuspid .022”
D746CRL4221Roth Prescription Mandibular Arch 1st Bicuspid .022”
D746CRL4181Roth Prescription Mandibular Arch 1st Bicuspid .018”
D746CRL322RHK1Roth Prescription Mandibular Arch Cuspid with Hook .022”
D746CRL318R1Roth Prescription Mandibular Arch Cuspid .018” Slot Ceramic Aesthetic Bracket
D746FSU2221Standard Edgewise Upper Lateral .022” Slot Crystal Clear Composite Bracket
D746FSU1221Standard Edgewise Upper Central .022” Slot Crystal Clear Composite Bracket
D746FSU1181Standard Edgewise Upper Central .018 Slot Crystal Clear Composite Bracket
D746FSL1221Standard Edgewise Lower Anteriors .022” Slot Crystal Clear Composite Bracket
D746FSL1181Standard Edgewise Lower Anteriors .018” Slot Crystal Clear Composite Bracket
D746FS3221Standard Edgewise Cuspids .022” Slot Crystal Clear Composite Bracket
D746FS22BI1Standard Edgewise Bicuspids .022” Slot Crystal Clear Composite Bracket
D746FRU322RHK1Roth Prescription Maxillary Arch Cuspid with Hook .022”
D746FRU322R1Roth Prescription Maxillary Arch Cuspid no Hook .022”
D746FRU322LHK1Roth Prescription Maxillary Arch Cuspid with Hook .022”
D746FRU322L1Roth Prescription Maxillary Arch Cuspid no Hook .022”
D746FRU318RHK1Roth Prescription Maxillary Arch Cuspid with Hook .018”
D746FRU318R1Roth Prescription Maxillary Arch Cuspid no Hook .018”
D746FRU318LHK1Roth Prescription Maxillary Arch Cuspid with Hook .018”
D746FRU318L1Roth Prescription Maxillary Arch Cuspid no Hook .018”
D746FRU22BI1Roth Prescription Maxillary Arch Bicuspid no Hook .022”
D746FRU222R1Roth Prescription Maxillary Arch Lateral .022”
D746FRU222L1Roth Prescription Maxillary Arch Lateral .022”
D746FRU218R1Roth Prescription Maxillary Arch Lateral .018”
D746FRU218L1Roth Prescription Maxillary Arch Lateral .018”
D746FRU18BIHK1Roth Prescription Maxillary Arch Bicuspid with Hook .018”
D746FRU18BI1Roth Prescription Maxillary Arch Bicuspid no Hook .018”
D746FRU122R1Roth Prescription Maxillary Arch Central .022”
D746FRU122L1Roth Prescription Maxillary Arch Central .022”
D746FRU118R1Roth Prescription Maxillary Arch Central .018”
D746FRU118L1Roth Prescription Maxillary Arch Central .018”
D746FRL5221Roth Prescription Mandibular Arch Lower 2nd Bicuspid no Hook .022”
D746FRL518HK1Roth Prescription Mandibular Arch Lower 2nd Bicuspid with Hook .018”
D746FRL5181Roth Prescription Mandibular Arch Lower 2nd Bicuspid no Hook .018”
D746FRL422HK1Roth Prescription Mandibular Arch Lower 1st Bicuspid with Hook .022”
D746FRL418HK1Roth Prescription Mandibular Arch Lower 1st Bicuspid with Hook .018”

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