Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015173183

FEI Number

3015173183

Entity Name

3DIEMME SRL

City/State/Country

Cantu Como, IT

Establishment Address

Via Risorgimento 9, Cantu Como 22063, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

3DIEMME Srl (Owner Number: 10059505)

Owner / Operator Contact Address

Via Risorgimento 9, Cantu, IT-CO 22063, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Universal RealGUIDE box RealGuide Software Suite AIS 3D app DRILL BIT BONE CREST LEVELER TORQUE WRENCH EXTENSION MOUTH OPENING GAUGE RealGUIDE IMPLANT MOUNT TISSUE PUNCH SQUARE CONNECTOR FOR HANDPIECE RealGUIDE SLEEVE ANCHOR PINS DRILL EVOBITE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-10-30
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-01-29
QRQ	Non-Irrigation Endosseous Dental Implant Drill Bits	Dental	Class 1	872.3980	2022-07-21
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2020-04-24
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2022-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

Henrique Nomelini Muniz Business: ZimVie US Corp LLC Email: 3ipbg-Regulatoryaffairs@Zimvie.com Phone: (561) 7766700

Related Public Records

Same Entity

3DIEMME Srl

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015173183. Last updated year: 2026. Please use registration number 3015173183 when referencing this establishment in official correspondence.