Estemp Eugenol Temporary Cement 101-1011

GUDID 20200305180030

Spident Co., Ltd.

Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement Ethoxy benzoic acid dental cement

• Primary Device ID: 20200305180030
• NIH Device Record Key: 4b06e4be-583e-4631-884a-575e542d9e94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Estemp Eugenol Temporary Cement
• Version Model Number: 101-1011
• Catalog Number: 101-1011
• 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	00000202207269 [Package]; Contains: 08809262954210; Package: [40 Units]; Discontinued: 2022-07-26; In Commercial Distribution
GS1	00202101110279 [Package]; Contains: 08809262954210; Package: [20 Units]; In Commercial Distribution
GS1	08809262954210 [Primary]
GS1	20200305180030 [Package]; Contains: 08809262954210; Package: [10 Units]; Discontinued: 2019-05-16; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100290

FDA Product Code

• EMA: Cement, Dental

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: 2019-05-17
• Device Publish Date: 2018-08-23

Devices Manufactured by Spident Co., Ltd.

• 08809262954173 - Tempro Blue: 2021-01-26 Light cured, single component, provisional filling material for temporary restorations.
• 08809262954524 - Base It: 2021-01-26 Light-cured base/liner containing calcium hydroxyapatite in urethane methacrylate oligomer.
• 20200623170027 - EsFlow LV A2 Syringe: 2021-01-26
• 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
• 08809262955576 - EsCom 100 A1 Capsules: 2021-01-26
• 20200523170066 - EsCom 100 A3.5 Capsules: 2021-01-26