Temp Fix

GUDID D8701019161

Temp Fix Disc, 95 X 16mm, Shade A4

Harvest Dental Products, LLC

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• Primary Device ID: D8701019161
• NIH Device Record Key: 4b425d0d-8079-4046-9170-dcd3dad18d6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Temp Fix
• Version Model Number: 1019-16
• Company DUNS: 794668751
• Company Name: Harvest Dental Products, 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: false
• 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: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8701019161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102341

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-24
• Device Publish Date: 2021-05-14

On-Brand Devices [Temp Fix]

• D8701023201: Temp Fix Disc, 98 X 20mm, Shade B2
• D8701022201: Temp Fix Disc, 98 X 20mm, Shade B1
• D8701019201: Temp Fix Disc, 98 X 20mm, Shade A3
• D8701019161: Temp Fix Disc, 95 X 16mm, Shade A4
• D8701018201: Temp Fix Disc, 98 X 20mm, Shade A2
• D8701017201: Temp Fix Disc, 98 X 20mm, Shade A1
• D8701016201: Temp Fix Disc, 98 X 20mm, Shade A0
• D870102620: Temp Fix Disc, 98 X 20mm, Shade C1