Estemp Eugenol Temporary Cement

Basic Information

• Brand Name: Estemp Eugenol Temporary Cement
• Primary DI: 08809262954210
• Version / Model: 101-1011
• Catalog Number: 101-1011
• Company Name: Spident Co., Ltd.
• Labeler DUNS: 689370711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-23
• Public Version: 4
• Public Version Date: 2022-07-26
• Public Version Status: Update
• Public Device Record Key: 4b06e4be-583e-4631-884a-575e542d9e94

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMA	Cement, Dental	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16703	Ethoxy benzoic acid dental cement	A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between ethoxy benzoic acid (EBA) and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20200305180030	GS1		10	Not in Commercial Distribution	2019-05-16
Primary	08809262954210	GS1
Package	00202101110279	GS1		20	Not in Commercial Distribution	2021-01-25
Package	00000202207269	GS1		40	Not in Commercial Distribution	2022-07-26

Premarket Submissions

Submission Number	Supplement Number
K100290	000