NOVA-S SAPPHIRE 466-001

GUDID D90946600103

.018 U1R NOVA-S SAPPHIRE BRACKET - MBT (5)

Ortho Arch Company Inc

Orthodontic bracket, ceramic

• Primary Device ID: D90946600103
• NIH Device Record Key: f629d922-e31f-41cf-838c-ae99ad459b97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA-S SAPPHIRE
• Version Model Number: .018 U1R
• Catalog Number: 466-001
• 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	D90946600103 [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: 2022-04-30

On-Brand Devices [NOVA-S SAPPHIRE]

• D90946601104: .018 U2R NOVA-S SAPPHIRE BRACKET - MBT (5)
• D90946600204: .018 U1L NOVA-S SAPPHIRE BRACKET - MBT (5)
• D90946600103: .018 U1R NOVA-S SAPPHIRE BRACKET - MBT (5)
• D9094660730: .018 LBIC NOVA-S SAPPHIRE BRACKET -17T (5)
• D9094660720: .018 L5L NOVA-S SAPPHIRE BRACKET -17T HOOK (5)
• D9094660710: .018 L5R NOVA-S SAPPHIRE BRACKET -17T HOOK (5)
• D9094660630: .018 LBIC NOVA-S SAPPHIRE BRACKET -12T (5)
• D9094660620: .018 L4L NOVA-S SAPPHIRE BRACKET -12T HOOK (5)
• D90946606109: .018 L4R NOVA-S SAPPHIRE BRACKET -12T HOOK (5)
• D90946605209: .018 L3L NOVA-S SAPPHIRE BRACKET - HK MBT (5)
• D90946605108: .018 L3R NOVA-S SAPPHIRE BRACKET - HK MBT (5)
• D9094660450: .018 LA NOVA-S SAPPHIRE BRACKET - MBT (5)
• D90946603308: .018 UBIC NOVA-S SAPPHIRE BRACKET - MBT (5)
• D90946603207: .018 UBICL NOVA-S SAPPHIRE BRACKET - HK MBT (5)
• D90946603106: .018 UBICR NOVA-S SAPPHIRE BRACKET - HK MBT (5)
• D90946602206: .018 U3L NOVA-S SAPPHIRE BRACKET - HK MBT (5)
• D90946601205: .018 U2L NOVA-S SAPPHIRE BRACKET - MBT (5)
• D90946602105: .018 U3R NOVA-S SAPPHIRE BRACKET - HK MBT (5)