Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022378059

FEI Number

3022378059

Entity Name

MC BIO S.R.L.

City/State/Country

Lomazzo Como, IT

Establishment Address

Via Cavour 2, Lomazzo Como 22074, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MC Bio s.r.l. (Owner Number: 10084869)

Owner / Operator Contact Address

Via Cavour 2, Lomazzo, IT-CO 22074, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MC Bio Supertack tack 5mm MC Bio Supertack tack 4mm MC Bio Supertack tack 3mm Handle - Asym - Ergal Handle - Straight MDF Handle - Straight SP (TiN) Advanced Set Back applicator Specialist Organizer Stainless Steel Tack Placement Instrument Offset tip Basic Set Long tip Starter Set Mallet Aluminum Tack Placement Instrument Tip with Indexable Stop Standard tip Tack Organizer Back applicator tip Offset tip SP GBR Modular set Handle - Asym - SP (TiN) Long tip SP Handle - Straight - Ergal Handle - Asym - Titanium Blade - Asym. S (5mm) Tank & Blade - Asym. 2XL (9mm) Blade - Straight M (6mm) Blade - Straight S (5mm) Tank & Blade - Asym. 3XL (10mm) Tank & Blade - Straight M (6mm) Blade - Straight XL (8mm) Tank & Blade - Straight XL (8mm) Blade - Asym. M (6mm) Blade - Straight 2XL (9mm) Tank & Blade - Asym. M (6mm) Blade - Asym. XL (8mm) Tank & Blade - Straight S (5mm) Blade - Asym. 3XL (10mm) Tank & Blade - Asym. S (5mm) Tank & Blade - Straight 2XL (9mm) Blade - Asym. 2XL (9mm) Tank & Blade - Asym. XL (8mm)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2022-04-20
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2022-04-08
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2025-06-20

Official Correspondent

Claudio Mangiacavalli

US Agent Details

Luigi Girotto Email: luigi.girotto@elikatech.com Phone: (626) 2563674

Related Public Records

Same Entity

MC Bio s.r.l.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022378059. Last updated year: 2026. Please use registration number 3022378059 when referencing this establishment in official correspondence.