Estemp NE Temporary Cement 101-1012

GUDID 08809262954227

Spident Co., Ltd.

Ethoxy benzoic acid dental cement

• Primary Device ID: 08809262954227
• NIH Device Record Key: 61d36bb5-3124-4971-8c43-40db5ef2bcb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Estemp NE Temporary Cement
• Version Model Number: 101-1012
• Catalog Number: 101-1012
• 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	00000202208198 [Package]; Package: [120 Units]; Discontinued: 2022-08-11; In Commercial Distribution
GS1	00202102110650 [Package]; Package: [96 Units]; In Commercial Distribution
GS1	00202102110667 [Package]; Package: [54 Units]; In Commercial Distribution
GS1	08809262954227 [Primary]

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