Impression Coping

Basic Information

• Brand Name: Impression Coping
• Primary DI: 08809728994293
• Version / Model: EIITN5012H
• Catalog Number: EIITN5012H
• Company Name: Megagen Implant Co. Ltd
• Labeler DUNS: 687388178
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-09
• Public Version: 1
• Public Version Date: 2023-11-17
• Public Version Status: New
• Public Device Record Key: 68e0b736-fde0-475f-94d6-b60cdd578249

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64321	Dental precision attachment simulator/analog, single-use	A device intended to be used to imitate or copy a dental precision attachment, or element that is part of a precision attachment, during fabrication of a final dental prosthesis (e.g., denture, crown, bridge) in the dental laboratory. It may be an instrument designed to reproduce the position, shape, and dimensions of a precision attachment, or it may be a copy of a precision attachment designed to enable fabrication of, or correct incorporation of, the final precision attachment in the dental prosthesis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809728994293	GS1