GC CROWNTEK™

Basic Information

• Brand Name: GC CROWNTEK™
• Primary DI: D6584120631
• Version / Model: 412063
• Catalog Number: 412063
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 175
• Record Status: Published
• Publish Date: 2017-02-10
• Public Version: 4
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: fe6e6caf-ca89-4eb2-aff6-277616496936
• Distribution End Date: 2018-05-01

Device Description

GC CROWNTEK™ Starter Package, 5 crowns each of 35 sizes, Upper Right Central Incisors: 1+.3, 1+.4, 1 +.5, 1+.6, 1+.7, Upper Right Cuspids 3+.5, 3+.6, Upper Left Central Incisors: +1.3, _1.4, +1.5, +1.6, +1.7, Upper Left Cuspids: +3.5, +3.6, Upper Right Laterals: 2+.2, 2+.3, 2+.4, 2+.5, Lower Right Cuspids: 3-.3, 3-.4, Upper Left Laterals: +2.2, +2.3, +2.4, +2.5, Lower Left Cuspids: -3.3, -3.4, Lower Centrals & Laterals: -1-2-.6, -1-2-.7, Bicuspids: 2, 3, 4, 5, 6, 7. 8

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: No
• 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
Primary	D6584120631	HIBCC
Unit of Use	D6584120630	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room temperature