Shaper

FDA UDI

Class I (US FDA UDI)

by Micro Mega

Identity

Trade Name: SHAPER FDA UDI
Generic Name: Endodontic broach, serrated, reusable FDA UDI
Device Name: Endodontic instrument for professionnal dental use only FDA UDI
Model / Reference: n25 L21 FDA UDI
Description: Endodontic instrument for professionnal dental use only FDA UDI

Identifiers

Catalog Number: 20118007 FDA UDI
Primary DI / UDI-DI: J015201180071 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

Shaper by Micro Mega — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic broach, serrated, reusable.

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Henry Schein — HENRY SCHEIN, INC. · Class I
Henry Schein — HENRY SCHEIN, INC. · Class I
Barbed Broaches, 2-4, 25 — ENDOPERFECTION LIMITED · Class I
OPTIMUM — BENCO DENTAL SUPPLY CO. · Class I
KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
Barbed broaches 31mm 030, pu: 6 pcs — Diaswiss SA · Class I
OPTIMUM — BENCO DENTAL SUPPLY CO. · 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: Micro Mega

Sources (1)

FDA UDI 8ac419e9-4de2-499b-b6e5-3db1b2b5db47 34 fields · synced Jun 8, 2026