Restoration, Resin: Crown, Bridge, Temporary Inlay, Onlay, Splint

Basic Information

• Brand Name: Restoration, Resin: Crown, Bridge, Temporary Inlay, Onlay, Splint
• Primary DI: 06970617030032
• Version / Model: Not Applicable
• Company Name: SHENZHEN MINGHAO DENTURES CO., LTD.
• Labeler DUNS: 526027843
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: dac5b7e8-50af-4c46-a600-b7177c8134d2

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ultraviolet Light

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
Primary	06970617030032	GS1