EasyGum Strip - Modifier 9856

GUDID D87098561

EasyGum™ Flow Intense Modifier Bright Red

Harvest Dental Products, LLC

Dental composite resin

• Primary Device ID: D87098561
• NIH Device Record Key: bd7ea8fd-49dc-4d73-8e36-c47ee02677ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyGum Strip - Modifier
• Version Model Number: 9856
• Catalog Number: 9856
• 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	D87098561 [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: 2024-09-18
• Device Publish Date: 2024-09-10

On-Brand Devices [EasyGum Strip - Modifier]

• D87098601: EasyGum™ Flow Intense Modifier Dark Violet
• D87098581: EasyGum™ Flow Intense Modifier Night Blue
• D87098561: EasyGum™ Flow Intense Modifier Bright Red
• D87098541: EasyGum™ Flow Intense Modifier Dark Red/Plum 1g
• D87098521: EasyGum™ Flow Intense Modifier Cream 1g
• D87098501: EasyGum™ Flow Modifier, 3g, Pink Opaque
• D87098481: EasyGum™ Flow Modifier, 3g, Pink Translucent
• D87098461: EasyGum™ Flow Modifier, 3g, Dark Reddish Pink
• D87098441: EasyGum™ Flow Modifier, 3g, Light Reddish Pink
• D87098421: EasyGum™ Flow Modifier, 3g, Light Pink
• D87098401: EasyGum™ Flow Modifier, 3g, Original Pink