NOVA -S SAPPHIRE BRACKET 466-445

GUDID D9094664450

.022 LA NOVA -S SAPPHIRE BRACKET - ROTH (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 Orthodontic bracket, ceramic Orthodontic bracket, ceramic 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