BONDER HANDLE 700-002

GUDID D9097000021

BONDER HANDLE

Ortho Arch Company Inc

Dental material application tool, single-use

• Primary Device ID: D9097000021
• NIH Device Record Key: 10487ce3-11f4-454c-a453-c65639c81ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONDER HANDLE
• Version Model Number: 700-002
• Catalog Number: 700-002
• 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	D9097000021 [Primary]

FDA Product Code

• EGD: Wax, Dental, Intraoral

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: 2023-07-05
• Device Publish Date: 2023-06-27

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