Estemp NE Temporary Cement 101-1012

GUDID 08809262954227

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 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

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