EXACTFLOW

Basic Information

• Brand Name: EXACTFLOW
• Primary DI: D690TFHSM25S32
• Version / Model: UTFHSM25
• Catalog Number: TFHSM25S3
• Company Name: Ss White Burs, Inc.
• Labeler DUNS: 151760014
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• 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: 66257b80-0817-4a90-8ca6-4338b674e15a

Device Description

EXACTFLOWH RECIPROCATING FILE SMALL 25MM STERILE - 3 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKS	FILE, PULP CANAL, ENDODONTIC	Dental	872.4565	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	D690TFHSM25S30	HIBCC
Primary	D690TFHSM25S32	HIBCC

Customer Contacts

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