NOVA-S SAPPHIRE 466-033

GUDID D90946603308

.018 UBIC NOVA-S SAPPHIRE 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

• Primary Device ID: D90946603308
• NIH Device Record Key: e3cc8e67-a7b4-4880-8f0e-1ae453115236
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA-S SAPPHIRE
• Version Model Number: .018 UBIC
• Catalog Number: 466-033
• 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	D90946603308 [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: 2022-05-11
• Device Publish Date: 2022-05-03

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)