Core It Yellow 101-0301

GUDID 08809262954838

Radiopaque, dual cured composite core build up material in tooth shade

Spident Co., Ltd.

Dental composite resin

• Primary Device ID: 08809262954838
• NIH Device Record Key: 67d5c639-75ab-4387-8861-2afde52ed576
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Core It Yellow
• Version Model Number: 101-0301
• Catalog Number: 101-0301
• 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

Customer Support Contacts

• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com
• Phone: 201-944-0511
• Email: spident.usa@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00000202209065 [Package]; Package: [130 Units]; Discontinued: 2022-09-06; In Commercial Distribution
GS1	00202102110568 [Package]; Package: [100 Units]; In Commercial Distribution
GS1	08809262954838 [Primary]
GS1	20200205170650 [Package]; Package: [100 Units]; Discontinued: 2019-05-16; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092572

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: 6
• Public Version Date: 2019-05-17
• Device Publish Date: 2017-02-20

Devices Manufactured by Spident Co., Ltd.

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• 08809262950014 - EsFlow PLUS: 2025-08-08 EsFlow PLUS A2 2.5g x 2sy
• 08809262950021 - EsFlow PLUS: 2025-08-08 EsFlow PLUS A3 2.5g x 2sy
• 08809262950038 - EsFlow PLUS: 2025-08-08 EsFlow PLUS A3.5 2.5g x 2sy
• 08809262950045 - EsFlow PLUS: 2025-08-08 EsFlow PLUS B1 2.5g x 2sy
• 08809262950052 - EsFlow PLUS: 2025-08-08 EsFlow PLUS B2 2.5g x 2sy
• 08809262950069 - EsFlow PLUS: 2025-08-08 EsFlow PLUS AO 2.5g x 2sy
• 08809262950076 - EsFlow PLUS: 2025-08-08 EsFlow PLUS AE 2.5g x 2sy