Tempro Blue 101-1501

GUDID 08809262954173

Light cured, single component, provisional filling material for temporary restorations.

Spident Co., Ltd.

Dental composite resin

• Primary Device ID: 08809262954173
• NIH Device Record Key: 0d492446-2ede-4be4-ae99-539b9a6893de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tempro Blue
• Version Model Number: 101-1501
• Catalog Number: 101-1501
• 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
• Phone: 201-944-0511
• Email: Spident.usa@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015083020234 [Package]; Package: [20 Units]; Discontinued: 2023-08-30; In Commercial Distribution
GS1	08809262954173 [Primary]
GS1	20210212180016 [Package]; Package: [10 Units]; Discontinued: 2021-01-25; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100413

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: 2021-01-26
• Device Publish Date: 2017-02-20

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• 08809262950045 - EsFlow PLUS: 2025-08-08 EsFlow PLUS B1 2.5g x 2sy
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• 08809262950076 - EsFlow PLUS: 2025-08-08 EsFlow PLUS AE 2.5g x 2sy