Estemp Implant Cement

Basic Information

• Brand Name: Estemp Implant Cement
• Primary DI: 08809262954234
• Version / Model: 101-1013
• Catalog Number: 101-1013
• 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: 2021-01-26
• Public Version Status: Update
• Public Device Record Key: 8cd01507-0423-4c01-995d-cc296fa8d3d6

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
61482	Dental cement trial	A non-sterile substance intended to be used as a guide for selecting a good aesthetic match to the final dental cement to be used in a dental restoration of appliance procedure. It is typically supplied as a water-soluble paste consisting of glycerin, mineral fillers and pigments that does not cure and is intended to be washed off from the restoration and preparation surface prior to final cementation. 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	20200623170096	GS1		50	Not in Commercial Distribution	2019-05-16
Primary	08809262954234	GS1
Package	00202102110230	GS1		50	Not in Commercial Distribution	2021-01-25

Premarket Submissions

Submission Number	Supplement Number
K134021	000