3M™ ESPE™ Protemp™

Basic Information

• Brand Name: 3M™ ESPE™ Protemp™
• Primary DI: 30605861011410
• Version / Model: 50600TK
• Catalog Number: 50600TK
• Company Name: 3M COMPANY
• Labeler DUNS: 830016148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 2
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: d37c859f-d6b7-4cb0-885d-635aa3351733

Device Description

3M™ ESPE™ Protemp™ Crown Temporization Material Trial Kit, 50600TK

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: 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
ELZ	CROWN, PREFORMED	Dental	872.3330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34976	Preformed dental crown, temporary	A prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50605861011414	GS1	BOX	10	In Commercial Distribution
Primary	30605861011410	GS1
Unit of Use	00605861011419	GS1

Customer Contacts

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