DentaSonic

Basic Information

• Brand Name: DentaSonic
• Primary DI: E53555FDM051601
• Version / Model: 55-FDM0-5160
• Catalog Number: 55-FDM0-5160
• Company Name: Gc Orthodontics America Inc.
• Labeler DUNS: 063167128
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2021-08-26
• Public Version: 1
• Public Version Date: 2021-09-03
• Public Version Status: New
• Public Device Record Key: 87adca07-0507-4e66-a185-11e8144d0e39

Device Description

DS DIASTRIP REFILL 1-SIDE 60 MICRON PK5

Device Characteristics

• Single Use: No
• 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
EMI	FILE, BONE, SURGICAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31863	Margin finishing dental file/rasp, reusable	A hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	E53555FDM051600	HIBCC
Primary	E53555FDM051601	HIBCC

Customer Contacts

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