NOVA -S SAPPHIRE BRACKET 466-445

GUDID D9094664450

.022 LA NOVA -S SAPPHIRE BRACKET - ROTH (5)

Ortho Arch Company Inc

Orthodontic bracket, ceramic

• Primary Device ID: D9094664450
• NIH Device Record Key: 09433545-fba2-4bfb-af27-a1948da7d132
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA -S SAPPHIRE BRACKET
• Version Model Number: 466-445
• Catalog Number: 466-445
• Company DUNS: 020956330
• Company Name: Ortho Arch Company Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	D9094664450 [Primary]

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: 2023-07-03
• Device Publish Date: 2023-06-23

Devices Manufactured by Ortho Arch Company Inc

• D9098001290 - SPECTRUM: 2023-07-06 SPECTRUM LINGUAL ARCH FORMING PLIER
• D9098001302 - SPECTRUM: 2023-07-06 SPECTRUM TORQUING PLIER SET W/ WIDE KEY
• D9098001311 - SPECTRUM: 2023-07-06 SPECTRUM WIDE REPLACEMENT KEY
• D9098001321 - SPECTRUM: 2023-07-06 SPECTRUM THREE PRONG FACEMASK/ FACEBOW PLIER
• D90980014111 - MOLAR OPENING TOOL: 2023-07-06 SLB MOLAR OPENING TOOL
• D90980014616 - OPENING TOOL: 2023-07-06 ECLIPSE SLB OPENING TOOL
• D90980014717 - CLOSING TOOL: 2023-07-06 ECLIPSE SLB CLOSING TOOL
• D90980014818 - ECLIPSE SLB CLOSING TOOL: 2023-07-06 ECLIPSE SLB CLOSING TOOL W/ WIRE DIRECTOR