SSW ENDO

Basic Information

• Brand Name: SSW ENDO
• Primary DI: D690TFHAS212
• Version / Model: NONE
• Catalog Number: TFHAS21
• Company Name: Ss White Burs, Inc.
• Labeler DUNS: 151760014
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2025-02-17
• Public Version: 2
• Public Version Date: 2025-05-09
• Public Version Status: Update
• Public Device Record Key: b92c3782-4611-4876-bec6-87a816ac262b

Device Description

EXACTFLOWH RECIPROCATING FILE SM-PR-MD-LG 21MM ASSORTED - 4 PACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EKM	GUTTA-PERCHA	Dental	872.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63550	Rotary/reciprocating endodontic file/rasp, single-use	A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D690TFHAS210	HIBCC
Primary	D690TFHAS212	HIBCC

Customer Contacts

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