Allgilloid Plus™ Chromatic Mint Alginate 600-643M

GUDID 00842452100712

Chromatic (Color Changing) Impression Material For Dental Molds / Mint Flavor

ORTHO SPECIALTIES

Alginate dental impression material

• Primary Device ID: 00842452100712
• NIH Device Record Key: b9f6a9bd-8159-49b7-87cf-5f8caece6cd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allgilloid Plus™ Chromatic Mint Alginate
• Version Model Number: 600-643M
• Catalog Number: 600-643M
• Company DUNS: 011050583
• Company Name: ORTHO SPECIALTIES
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-637-1237
• Email: contactus@orthospecialties.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842452100712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974894

FDA Product Code

• ELW: Material, Impression

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: 2016-09-24

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