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 ID: D90946503105
• NIH Device Record Key: 6571872a-f1cf-4ba5-9476-d1bd094c6f73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA C CERAMIC
• Version Model Number: .018 UBIR -HK
• Catalog Number: 465-031
• Company DUNS: 020956330
• Company Name: Ortho Arch Company 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: true
• 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
HIBCC	D90946503105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142729

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: 2022-05-09
• Device Publish Date: 2022-04-29

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)