NOVA C CERAMIC 464-012

GUDID D90946401203

.018 U2L NOVA C CERAMIC BRACKET - MBT (5)

Ortho Arch Company Inc

Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic

• Primary Device ID: D90946401203
• NIH Device Record Key: b464dad8-81ba-4a87-a82b-1f78963e5183
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA C CERAMIC
• Version Model Number: .018 U2L
• Catalog Number: 464-012
• 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	D90946401203 [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: 2022-05-03
• Device Publish Date: 2022-04-25

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)