Midway Select

FDA UDI

Class I (US FDA UDI)

by Midway Dental Supply, Llc

Identity

Trade Name: Midway Select FDA UDI
Generic Name: Manual endodontic file/rasp, single-use FDA UDI
Device Name: Stainless Steel K Files (Hand), Size # 10, Length 25 mm FDA UDI
Model / Reference: 002-0395 FDA UDI
Description: Stainless Steel K Files (Hand), Size # 10, Length 25 mm FDA UDI

Identifiers

Primary DI / UDI-DI: 10843717103902 FDA UDI
FDA Product Code: EKS FDA UDI
GMDN Term: Manual endodontic file/rasp, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual endodontic file/rasp, single-use

Midway Select by Midway Dental Supply, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual endodontic file/rasp, single-use.

EdgeGates™ — US Endodontics, LLC · Class I
Hedstrom-Files — TULSA DENTAL PRODUCTS LLC · Class I
Endodontic Hand Instrument — TULSA DENTAL PRODUCTS LLC · Class I
Endodontic Hand Instruments — TULSA DENTAL PRODUCTS LLC · Class I
3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
K-Files — TULSA DENTAL PRODUCTS LLC · Class I
K-REAMERS — TULSA DENTAL PRODUCTS LLC · Class I
K-Files — TULSA DENTAL PRODUCTS LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Midway Dental Supply, Llc

Sources (1)

FDA UDI 8565e01b-a0e6-4952-88d9-22c65e76df1c 33 fields · synced May 31, 2026