EasyGum Strip

GUDID D870S979520

EasyGum™ Strip LC Comp, 4/pk, Original Pink

Harvest Dental Products, LLC

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• Primary Device ID: D870S979520
• NIH Device Record Key: f66172ab-9723-4657-a7c3-9991d7a3bae7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyGum Strip
• Version Model Number: 9802
• Company DUNS: 794668751
• Company Name: Harvest Dental Products, LLC
• Device Count: 2
• 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	D870980224 [Primary]
HIBCC	D870S979520 [Unit of Use]

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: 2024-06-14
• Device Publish Date: 2024-06-06

Devices Manufactured by Harvest Dental Products, LLC

• D870S979520 - EasyGum Strip: 2024-06-14EasyGum™ Strip LC Comp, 4/pk, Original Pink
• D870S979520 - EasyGum Strip: 2024-06-14 EasyGum™ Strip LC Comp, 4/pk, Original Pink
• D87060036141 - Harvest Nano Zirconia: 2024-05-03 Harvest Nano Zirconia ColorBlend OM2 98.5 x 14
• D87060036181 - Harvest Nano Zirconia: 2024-05-03 Harvest Nano Zirconia Color Blend OM2 98.5 x 18
• D87060036221 - Harvest Nano Zirconia: 2024-05-03 Harvest Nano Zirconia Color Blend OM2 98.5 x 22
• D87060036251 - Harvest Nano Zirconia: 2024-05-03 Harvest Nano Zirconia Color Blend 0M2 98.5 x 25
• D87060038141 - Harvest Nano Zirconia: 2024-05-03 Harvest Nano Zirconia ColorBlend A1 98.5 x 14
• D87060038181 - Harvest Nano Zirconia: 2024-05-03 Harvest Nano Zirconia Color Blend A1 98.5 x 18
• D87060038221 - Harvest Nano Zirconia: 2024-05-03 Harvest Nano Zirconia Color Blend A1 98.5 x 22