K-file hand instrument

FDA UDI

Class I (US FDA UDI)

by Tulsa Dental Products Llc

Identity

Trade Name: K-file hand instrument FDA UDI
Generic Name: Manual endodontic file/rasp, reusable FDA UDI
Device Name: K FILE: 006 25MM LEXICON STERILIZED FDA UDI
Model / Reference: KFS00625 FDA UDI
Description: K FILE: 006 25MM LEXICON STERILIZED FDA UDI

Identifiers

Catalog Number: KFS00625 FDA UDI
Primary DI / UDI-DI: D716KFS006251 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Manual endodontic file/rasp, reusable

K-file hand instrument by Tulsa Dental Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
SafeSiders — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
Hedstroem 015/31mm — LM-Instruments Oy · 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

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Manufacturer

Manufacturer: Tulsa Dental Products Llc

Sources (1)

FDA UDI 20568385-5a42-423f-938d-862032a0af27 34 fields · synced Jun 8, 2026