SCOTT'S HANDHELD AUTOMIX CORE 2/pk NATURAL A2 199-3070

GUDID D77819930701

SCOTT'S DENTAL SUPPLY L.L.C.

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• Primary Device ID: D77819930701
• NIH Device Record Key: 75689281-624d-4e7d-9a10-63b70a3c8522
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCOTT'S HANDHELD AUTOMIX CORE 2/pk NATURAL A2
• Version Model Number: 199-3070
• Catalog Number: 199-3070
• Company DUNS: 137217043
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D77819930701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022675

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-02