EasyGum Strip 9812

GUDID D870981225

EasyGum™ Strip LC Comp, 4/pk - Dark Reddish Pink Opaque

Harvest Dental Products, LLC

Dental composite resin

• Primary Device ID: D870981225
• NIH Device Record Key: 01ffdab0-edb8-4926-81f6-ee1c5ca5f6a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyGum Strip
• Version Model Number: 9812
• Catalog Number: 9812
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D870981225 [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: 2024-07-31
• Device Publish Date: 2024-07-23

On-Brand Devices [EasyGum Strip]

• D870S979520: EasyGum™ Strip LC Comp, 4/pk, Original Pink
• D87098361: EasyGum™ Strip LC Comp, Easy Bonk Kit
• D870981225: EasyGum™ Strip LC Comp, 4/pk - Dark Reddish Pink Opaque
• D870981023: EasyGum™ Strip LC Comp, 4/pk, Original Pink Opaque
• D87098082: EasyGum™ Strip LC Comp, 4/pk, Dark Reddish Pink
• D870980628: EasyGum™ Strip LC Comp, 4/pk, Light Reddish Pink
• D870980426: EasyGum™ Strip LC Comp, 4/pk, Light Pink
• D87097972: EasyGum™ Strip LC Comp Starter Kit
• D870980011: Harvest EasyGum® Composite Master Kit