Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012649815

FEI Number

3012649815

Entity Name

TRIDENT SRL

City/State/Country

Castenedolo Brescia, IT

Establishment Address

Via Artigiani 4, Castenedolo Brescia 25014, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Trident SRL (Owner Number: 10051619)

Owner / Operator Contact Address

Via Artigiani 4, Castenedolo, IT-BS 25014, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222666

PMA Number

N/A

All Registered Proprietary Names

Imaagen Sensor I-View Sensor I-View Silver BOOM sensor size 2 I-View Silver size 2 BOOM sensor TriScan Imagen Scan I-View Gold I-View Gold size 2 Blu Imagen Sensor Gold size 2 Imagen Sensor Gold Blu size 2 QuickScan PSP VieweR ReadeR X-VIEW 3D PAN; X-VIEW 2D PAN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2016-12-12
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2022-02-22
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2018-11-07
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2022-07-14
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2020-06-19
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2016-04-12
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2024-04-22

Official Correspondent

Giorgio Rizzo

US Agent Details

Joyce St Germain Business: The 510k Consulting, LLC Email: joyce510kfda@gmail.com Phone: (904) 4773203

Related Public Records

Same Entity

Trident 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
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Similar Registrations

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2032641	CYBER MEDICAL IMAGING, INC.	Los Angeles, CA, US
3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012649815. Last updated year: 2026. Please use registration number 3012649815 when referencing this establishment in official correspondence.