EsCom100 B2 Syringe 101-0708

GUDID 08809262955279

Nano-hybrid universal composite resin for posterior and anterior restorations.

Spident Co., Ltd.

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• Primary Device ID: 08809262955279
• NIH Device Record Key: 48850867-5a17-4536-988c-88b6e8159833
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EsCom100 B2 Syringe
• Version Model Number: 101-0708
• Catalog Number: 101-0708
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00000202309178 [Package]; Package: [20 Units]; Discontinued: 2023-09-17; In Commercial Distribution
GS1	00202201110018 [Package]; Package: [40 Units]; In Commercial Distribution
GS1	08809262955279 [Primary]
GS1	20200323170020 [Package]; Package: [20 Units]; Discontinued: 2019-05-31; 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: 7
• Public Version Date: 2019-05-31
• Device Publish Date: 2017-02-20

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