MD-Temp Plus(Pink)

Basic Information

• Brand Name: MD-Temp Plus(Pink)
• Primary DI: 08806387893141
• Version / Model: 9314
• Company Name: Meta Biomed Co., Ltd.
• Labeler DUNS: 688322841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-18
• Public Version: 3
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: d0902495-ed0d-43c2-a87e-b4529c413871

Device Description

MD-Temp Plus is used for temporary filling material. It is supplied in a 20, 30 or 40g jar in either white (tooth-like) or pink (gum-like), and individually boxed. It is intended primarily as a temporary filling material for most cavities or damages but may be used by the dentist for other temporary restorations. MD-Temp plus is water-based temporary filling materials used for part of a tooth or multiple teeth. The curing reaction is the hydration reaction of the gypsum, and the semi-gypsum is cured as it is exposed to saliva or water in the oral cavity.

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: 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
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806387893141	GS1