EsBond 101-0501

GUDID 08809262955415

5th Generation Bonding. Light Cured, single bottle application bonding system.

Spident Co., Ltd.

Dentine bonding agent/set

• Primary Device ID: 08809262955415
• NIH Device Record Key: 200b3ebf-f00a-4479-a76b-270843aa3c04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EsBond
• Version Model Number: 101-0501
• Catalog Number: 101-0501
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00000202309208 [Package]; Package: [150 Units]; Discontinued: 2023-09-20; In Commercial Distribution
GS1	00202202110062 [Package]; Package: [200 Units]; In Commercial Distribution
GS1	08809262955415 [Primary]
GS1	20210305180053 [Package]; Package: [100 Units]; Discontinued: 2019-05-16; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120767

FDA Product Code

• KLE: Agent, Tooth Bonding, 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.

• 08809262950007 - EsFlow PLUS: 2025-08-08 EsFlow PLUS A1 2.5g x 2sy
• 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