ZMD-1000B TEMPORARY

Basic Information

• Brand Name: ZMD-1000B TEMPORARY
• Primary DI: 08806169157126
• Version / Model: ZMD-1000B TEMPORARY
• Company Name: DENTIS CO. ,LTD
• Labeler DUNS: 694721181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-27
• Public Version: 4
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: 427ba89e-088a-40b9-8035-bfed0f0106f8

Device Description

Dental Temporary Resin / ZMD-1000B TEMPORARY

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EBG	Crown And Bridge, Temporary, Resin	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806169157126	GS1

Premarket Submissions

Submission Number	Supplement Number
K180657	000