Temp Esthetic

Basic Information

• Brand Name: Temp Esthetic
• Primary DI: D87010040161
• Version / Model: 10040-16
• Company Name: Harvest Dental Products, LLC
• Labeler DUNS: 794668751
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-14
• Public Version: 3
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: 080aa83c-68fa-4cd3-9643-c9a6f1f990c1

Device Description

Temp Esthetic Disc, 98.5 X 16mm, Shade A3

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: No
• 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	D87010040161	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]