Harvest EasyGum 9794

GUDID D87097941

OnX x EasyGum Trial Kit

Harvest Dental Products, LLC

Dental composite resin

• Primary Device ID: D87097941
• NIH Device Record Key: eb7a509a-1e51-4773-a9fd-91bdde33fbf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harvest EasyGum
• Version Model Number: 9794
• Catalog Number: 9794
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D87097941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231389

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2026-01-13
• Device Publish Date: 2026-01-05

On-Brand Devices [Harvest EasyGum]

• D87097941: OnX x EasyGum Trial Kit
• D87097961: EasyGum™ Demo Kit – 2 EasyGum Composite Strip Trays, Papilla Tool