Rispi

FDA UDI

Class I (US FDA UDI)

by Micro Mega

Identity

Trade Name: RISPI FDA UDI
Generic Name: Endodontic broach, serrated, reusable FDA UDI
Device Name: Endodontic instrument for professionnal dental use only FDA UDI
Model / Reference: n2 L19 FDA UDI
Description: Endodontic instrument for professionnal dental use only FDA UDI

Identifiers

Catalog Number: 20116005 FDA UDI
Primary DI / UDI-DI: J015201160051 FDA UDI
FDA Product Code: EKW FDA UDI
GMDN Term: Endodontic broach, serrated, 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endodontic broach, serrated, reusable

A comprehensive medical device directory listing for the RISPI endodontic instrument.

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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: Micro Mega

Sources (1)

FDA UDI fce4187b-60f8-4846-a5c1-3bcbe8421ba1 34 fields · synced Jun 21, 2026