NOVA C CERAMIC 465-031

GUDID D90946503105

.018 UBIR NOVA C CERAMIC BRACKET - HK ROTH (5)

Ortho Arch Company Inc

Orthodontic bracket, ceramic
Primary Device IDD90946503105
NIH Device Record Key6571872a-f1cf-4ba5-9476-d1bd094c6f73
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVA C CERAMIC
Version Model Number.018 UBIR -HK
Catalog Number465-031
Company DUNS020956330
Company NameOrtho Arch Company Inc
Device Count1
DM Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD90946503105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, Ceramic, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29

On-Brand Devices [NOVA C CERAMIC]

D90946401203.018 U2L NOVA C CERAMIC BRACKET - MBT (5)
D90946401102.018 U2R NOVA C CERAMIC BRACKET - MBT (5)
D90946400202.018 U1L NOVA C CERAMIC BRACKET - MBT (5)
D90946400101.018 U1R NOVA C CERAMIC BRACKET - MBT (5)
D90946405106.018 L3R NOVA C CERAMIC BRACKET - HK MBT (5)
D90946404509.018 LA NOVA C CERAMIC BRACKET - MBT (5)
D90946403306.018 UBIC NOVA C CERAMIC BRACKET - NO HOOK MBT (5)
D90946403205.018 UBIL NOVA C CERAMIC BRACKET - HK MBT (5)
D90946403104.018 UBIR NOVA C CERAMIC BRACKET - HK MBT (5)
D90946402204.018 U3L NOVA C CERAMIC BRACKET - HK MBT (5)
D90946402103.018 U3R NOVA C CERAMIC BRACKET - HK MBT (5)
D9094641730.022 LBIC NOVA C CERAMIC BRACKET -17T NO HOOK (5)
D9094641720.022 LBIL NOVA C CERAMIC BRACKET -17T HK (5)
D90946417109.022 LBIR NOVA C CERAMIC BRACKET - 17T HK (5)
D9094641630.022 LBIC NOVA C CERAMIC BRACKET -12T NO HOOK (5)
D90946416209.022 LBIL NOVA C CERAMIC BRACKET -12T HK (5)
D90946416108.022 LBIR NOVA C CERAMIC BRACKET -12T HK (5)
D90946415208.022 L3L NOVA C CERAMIC BRACKET - HK MBT (5)
D90946415107.022 L3R NOVA C CERAMIC BRACKET - HK MBT (5)
D9094641450.022 LA NOVA C CERAMIC BRACKET - MBT (5)
D90946413307.022 UBIC NOVA C CERAMIC BRACKET - NO HOOK MBT (5)
D90946413206.022 UBIL NOVA C CERAMIC BRACKET - HK MBT (5)
D90946413105.022 UBIR NOVA C CERAMIC BRACKET - HK MBT (5)
D90946412205.022 U3L NOVA C CERAMIC BRACKET - HK MBT (5)
D90946412104.022 U3R NOVA C CERAMIC BRACKET - HK MBT (5)
D90946411204.022 U2L NOVA C CERAMIC BRACKET - MBT (5)
D90946411103.022 U2R NOVA C CERAMIC BRACKET - MBT (5)
D90946410203.022 U1L NOVA C CERAMIC BRACKET - MBT (5)
D90946410102.022 U1R NOVA C CERAMIC BRACKET - MBT (5)
D9094640730.018 LBIC NOVA C CERAMIC BRACKET -17T NO HOOK (5)
D90946407209.018 LBIL NOVA C CERAMIC BRACKET -17T HK (5)
D90946407108.018 LBIR NOVA C CERAMIC BRACKET - 17T HK (5)
D90946406309.018 LBIC NOVA C CERAMIC BRACKET -12T NO HOOK (5)
D90946406107.018 LBIR NOVA C CERAMIC BRACKET -12T HK (5)
D90946405207.018 L3L NOVA C CERAMIC BRACKET - HK MBT (5)
D9094651740.022 NOVA-C CERAMIC ROTH RX LOWER 2ND BI'S NO HOOK (5)
D9094651730.022 LBIC NOVA -C CERAMIC BRACKET -22T NO HOOK (5)
D9094651720.022 LBIL NOVA-C CERAMIC BRACKET -22T HK (5)
D9094651710.022 LBIR NOVA -C CERAMIC BRACKET - 22T HK (5)
D9094651640.022 NOVA-C CERAMIC ROTH RX LOWER 1ST BI'S NO HOOK (5)
D9094651630.022 LBIC NOVA -C CERAMIC BRACKET -17T NO HOOK (5)
D9094651620.022 LBIL NOVA-C CERAMIC BRACKET -17T HK (5)
D90946516109.022 LBIR NOVA -C CERAMIC BRACKET -17T HK (5)
D90946515209.022 L3L NOVA -C CERAMIC BRACKET - HK ROTH (5)
D90946515108.022 L3R NOVA -C CERAMIC BRACKET - HK ROTH (5)
D9094651450.022 LA NOVA -C CERAMIC BRACKET - ROTH (5)
D90946513409.022 NOVA C CERAMIC ROTH RX UPPER BI'S NO HOOK (5)
D90946513308.022 UBIC NOVA -C CERAMIC BRACKET - NO HOOK ROTH (5)
D90946513207.022 UBIL NOVA-C CERAMIC BRACKET - HK ROTH (5)
D90946513106.022 UBIR NOVA -C CERAMIC BRACKET - HK ROTH (5)

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