NOVA-S-SAPPHIRE BRACKET 466-302

GUDID D90946630207

.018 U1L NOVA-S SAPPHIRE BRACKET - ROTH (5)

Ortho Arch Company Inc

Orthodontic bracket, ceramic

• Primary Device ID: D90946630207
• NIH Device Record Key: 5185e93e-ec1e-4593-9697-4c0800634457
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA-S-SAPPHIRE BRACKET
• Version Model Number: .018 U1L ROTH
• Catalog Number: 466-302
• 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	D90946630207 [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: 2022-06-09
• Device Publish Date: 2022-06-01

On-Brand Devices [NOVA-S-SAPPHIRE BRACKET]

• D90946623108: .022 UBICR NOVA-S SAPPHIRE BRACKET - HK MBT (5)
• D90946622208: .022 U3L NOVA-S SAPPHIRE BRACKET - HK MBT (5)
• D90946622107: .022 U3R NOVA-S SAPPHIRE BRACKET - HK MBT (5)
• D90946621207: .022 U2L NOVA-S SAPPHIRE BRACKET - MBT (5)
• D90946621106: .022 U2R NOVA-S SAPPHIRE BRACKET - MBT (5)
• D90946620206: .022 U1L NOVA-S SAPPHIRE BRACKET - MBT (5)
• D90946620105: .022 U1R NOVA-S-SAPPHIRE BRACKET - MBT (5)
• D9094664310: .022 UBICR NOVA -S SAPPHIRE BRACKET W- HK ROTH (5)
• D9094664220: .022 U3L NOVA -S SAPPHIRE BRACKET - HK ROTH (5)
• D90946642109: .022 U3R NOVA -S SAPPHIRE BRACKET - HK ROTH (5)
• D90946641209: .022 U2L NOVA -S SAPPHIRE BRACKET - ROTH (5)
• D90946641108: .022 U2R NOVA -S SAPPHIRE BRACKET - ROTH (5)
• D90946640208: .022 U1L NOVA-S SAPPHIRE BRACKET - ROTH (5)
• D90946640107: .022 U1R NOVA-S SAPPHIRE BRACKET - ROTH (5)
• D9094663730: .018 LBIC NOVA-S SAPPHIRE BRACKET -22T (5)
• D9094663720: .018 L5L NOVA-S SAPPHIRE BRACKET -22T HOOK (5)
• D9094663710: .018 L5R NOVA-S SAPPHIRE BRACKET -22T HOOK (5)
• D9094663630: .018 LBIC NOVA-S SAPPHIRE BRACKET -17T (5
• D9094663620: .018 L4L NOVA-S SAPPHIRE BRACKET -17T HOOK (5)
• D9094663610: .018 L4R NOVA-S SAPPHIRE BRACKET -17T HOOK (5)
• D9094663520: .018 L3L NOVA-S SAPPHIRE BRACKET - HK ROTH (5)
• D9094663510: .018 L3R NOVA-S SAPPHIRE BRACKET - HK ROTH (5)
• D9094663450: .018 LA NOVA-S SAPPHIRE BRACKET - ROTH (5)
• D9094663330: .018 UBIC NOVA-S SAPPHIRE BRACKET - ROTH (5)
• D9094663320: .018 UBICL NOVA-S SAPPHIRE BRACKET - HK ROTH (5)
• D90946633109: .018 UBICR NOVA-S SAPPHIRE BRACKET - HK ROTH (5)
• D90946632209: .018 U3L NOVA-S SAPPHIRE BRACKET - HK ROTH (5)
• D90946632108: .018 U3R NOVA-S SAPPHIRE BRACKET - HK ROTH (5)
• D90946631208: .018 U2L NOVA-S SAPPHIRE BRACKET - ROTH (5)
• D90946631107: .018 U2R NOVA-S SAPPHIRE BRACKET - ROTH (5)
• D90946630207: .018 U1L NOVA-S SAPPHIRE BRACKET - ROTH (5)
• D90946630106: .018 U1R NOVA-S SAPPHIRE BRACKET - ROTH (5)
• D9094662740: .022 L5L NOVA-S SAPPHIRE BRACKET -17T (5)
• D9094662730: .022 L5R NOVA-S SAPPHIRE BRACKET -17T (5)
• D9094662720: .022 L5L NOVA-S SAPPHIRE BRACKET -17T HOOK (5)
• D9094662710: .022 L5R NOVA-S SAPPHIRE BRACKET -17T HOOK (5)
• D9094662640: 022 L4L NOVA-S SAPPHIRE BRACKET -12T (5)
• D9094662630: .022 L4R NOVA-S SAPPHIRE BRACKET -12T (5)
• D9094662620: .022 L4L NOVA-S SAPPHIRE BRACKET -12T HOOK (5)
• D9094662610: .022 L4R NOVA-S SAPPHIRE BRACKET -12T HOOK (5)
• D9094662520: .022 L3L NOVA-S SAPPHIRE BRACKET - HK MBT (5)
• D9094662510: .022 L3R NOVA-S SAPPHIRE BRACKET - HK MBT (5)
• D9094662450: .022 LA NOVA-S SAPPHIRE BRACKET - MBT (5)
• D9094662340: .022 UBICL NOVA-S SAPPHIRE BRACKET - MBT (5)
• D90946623209: .022 UBICL NOVA-S SAPPHIRE BRACKET - HK MBT (50)