Estar-ZE

Basic Information

• Brand Name: Estar-ZE
• Primary DI: 08800209338926
• Version / Model: ZEHTA2020M
• Company Name: Osstem Implant Co.,Ltd.
• Labeler DUNS: 694893867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-03
• Public Version: 1
• Public Version Date: 2024-12-11
• Public Version Status: New
• Public Device Record Key: f649181c-e18a-496d-b349-54b227010fca

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIH	Powder, Porcelain	Dental	872.6660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38594	Custom-made dental crown, ceramic	A device made totally of ceramic material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800209338926	GS1

Premarket Submissions

Submission Number	Supplement Number
K242521	000