ZMD-1000B Model

Basic Information

• Brand Name: ZMD-1000B Model
• Primary DI: 08800053015035
• Version / Model: ZMD-1000B Model
• Company Name: DENTIS CO. ,LTD
• Labeler DUNS: 694721181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-03
• Public Version: 1
• Public Version Date: 2021-06-11
• Public Version Status: New
• Public Device Record Key: 19c8aa5f-19a0-4254-96f1-06d1981b84c8

Device Description

Dental Model Resin / ZMD-1000B Model

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: No
• 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
31176	Tactile orientation material	A device used by a person with a disability who has an impaired sense of orientation, typically a blind person, to self-orient in their surroundings, e.g., at home, work, and in the normal daily life of society. It consists of special tactile-material, including structured surfaces, to provide the user with information pertaining to their surroundings and function as signs to provide the user with known orientation points.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800053015035	GS1