EsCom 100 B1 Syringe 101-0709

GUDID 20210205180023

Spident Co., Ltd.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 20210205180023
• NIH Device Record Key: 3381ebb3-20ae-4104-8da9-8287256bcfca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EsCom 100 B1 Syringe
• Version Model Number: 101-0709
• Catalog Number: 101-0709
• Company DUNS: 689370711
• Company Name: Spident Co., Ltd.
• 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: false
• 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
GS1	08809262955262 [Primary]
GS1	20210205180023 [Package]; Contains: 08809262955262; Package: [20 Units]; Discontinued: 2021-01-25; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110428

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-01-26
• Device Publish Date: 2018-08-23

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