EsCom 100 B1 Syringe 101-0709

GUDID 20210205180023

Spident Co., Ltd.

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

Devices Manufactured by Spident Co., Ltd.

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• 20200723170026 - EsFlow LV A3 Syringe: 2021-01-26
• 00210205180012 - EsCom100 A4 Syringe: 2021-01-26 Nano-hybrid universal composite resin for posterior and anterior restorations.
• 20210205180023 - EsCom 100 B1 Syringe: 2021-01-26
• 20210205180023 - EsCom 100 B1 Syringe: 2021-01-26
• 08809262955576 - EsCom 100 A1 Capsules: 2021-01-26
• 20200523170066 - EsCom 100 A3.5 Capsules: 2021-01-26