InstaTemp® Max Temp. Material A1 76g cart., 15 mixing tips

GUDID 00841549100383

A temporary crown and bridge material refill for temporary crowns and bridges, long term temporaries and provisional inlays, onlays, and veneers.

STERNGOLD DENTAL LLC

Dental composite resin

• Primary Device ID: 00841549100383
• NIH Device Record Key: 682e0de3-f696-459e-845e-2f8e998455a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InstaTemp® Max Temp. Material A1 76g cart., 15 mixing tips
• Version Model Number: 220216
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• 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: true
• 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: 401-871-3489
• Email: maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549100383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013674

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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: 2020-01-09
• Device Publish Date: 2017-02-20

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