DiaFlexy-R 25mm 080

FDA UDI

Class I (US FDA UDI)

by Diaswiss SA

Identity

Trade Name: DiaFlexy-R 25mm 080 FDA UDI
Generic Name: Manual endodontic file/rasp, reusable FDA UDI
Device Name: Rotary instrument for endodontic intraoral use FDA UDI
Model / Reference: 925025R.080-0 FDA UDI
Description: Rotary instrument for endodontic intraoral use FDA UDI

Identifiers

Primary DI / UDI-DI: 07630049955820 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

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

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, reusable

DiaFlexy-R 25mm 080 by Diaswiss SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Manual endodontic file/rasp, reusable.

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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
SafeSiders — ESSENTIAL DENTAL SYSTEMS, INC. · 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: Diaswiss SA

Sources (1)

FDA UDI 68c8e721-542e-4b11-a6e3-f064d5e75387 33 fields · synced May 29, 2026