NOVA-S SAPPHIRE BRACKET 466-234

GUDID D9094662330

.022 UBICL NOVA-S SAPPHIRE BRACKET - MBT (5)

Ortho Arch Company Inc

Orthodontic bracket, ceramic

• Primary Device ID: D9094662330
• NIH Device Record Key: 7194ed4e-abc7-4326-9462-8ec90f4bf8c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA-S SAPPHIRE BRACKET
• Version Model Number: .022 UBICL - MBT
• Catalog Number: 466-234
• 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	D9094662330 [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: 2022-06-08
• Device Publish Date: 2022-05-31

On-Brand Devices [NOVA-S SAPPHIRE BRACKET]

• D9094662330: .022 UBICL NOVA-S SAPPHIRE BRACKET - MBT (5)
• D9094664720: .022 L5L NOVA-S SAPPHIRE BRACKET -22T HOOK (5)
• D9094664620: .022 L4L NOVA-S SAPPHIRE BRACKET -17T HOOK (5)
• D9094664510: .022 L3R NOVA-S SAPPHIRE BRACKET - HK ROTH (5)