DIRECTCROWN

Basic Information

• Brand Name: DIRECTCROWN
• Primary DI: D752AK3
• Version / Model: AK
• Company Name: DIRECT CROWN PRODUCTS
• Labeler DUNS: 120580910
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 114
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 425b6e29-7a13-422a-ae1c-dcf148e8e01e

Device Description

ADULT POLYCARBONATE POSTERIOR KIT CONTAINING 1OZ ACRYLIC LIQUID, 1OZ ACRYLIC POWDER AND 112 CROWN SHELLS SIZES 1-16 OPAQUE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
37542	Dental bridge, polymer	A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D752AK3	HIBCC
Unit of Use	D752AK	HIBCC

Customer Contacts

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