The Class II Approach 642502

GUDID D0026425021

The Class II Approach Evaluation Kit

DENTSPLY INTERNATIONAL INC.

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• Primary Device ID: D0026425021
• NIH Device Record Key: 481a776b-7485-4895-ba60-ca0dbf0543f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Class II Approach
• Version Model Number: 642502
• Catalog Number: 642502
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026425021 [Primary]

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: 2024-04-22
• Device Publish Date: 2024-04-12

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