Henry Schein

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name: Henry Schein FDA UDI
Generic Name: Manual endodontic file/rasp, reusable FDA UDI
Device Name: Endoflex K-Files 25 mm FDA UDI
Model / Reference: 1000386 FDA UDI
Description: Endoflex K-Files 25 mm FDA UDI

Identifiers

Catalog Number: 1000386 FDA UDI
Primary DI / UDI-DI: 00304040062340 FDA UDI
FDA Product Code: EKS FDA UDI
GMDN Term: Manual endodontic file/rasp, reusable 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

Yes

FDA UDI

Single Use

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual endodontic file/rasp, reusable

Henry Schein by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual endodontic file/rasp, reusable.

K-Files 21mm 070, pu: 6 pcs — Diaswiss SA · Class I
REAMERS — DiaDent Group International · Class I
K-Files — MICRO MEGA · Class I
Hand instrument K-file — TULSA DENTAL PRODUCTS LLC · Class I
Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
ProFile .04 Taper Hand File — TULSA DENTAL PRODUCTS LLC · Class I
KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa

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

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Manufacturer

Manufacturer: Henry Schein, Inc.

Sources (1)

FDA UDI 07ae6f43-5ced-42dd-9540-9e20b134d6be 34 fields · synced May 30, 2026