Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020117925

FEI Number

3020117925

Entity Name

ATHLOS OY

City/State/Country

Espoo Uusimaa, FI

Establishment Address

Klovinpellontie 1-3, Espoo Uusimaa 02180, FI

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Athlos Oy (Owner Number: 10082517)

Owner / Operator Contact Address

Klovinpellontie 1-3, Espoo, FI-18 02180, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211688

PMA Number

N/A

All Registered Proprietary Names

Athlos-Air Holders DC-Air Holders Athlos-1 DC-Air Athlos-Air

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2021-08-09
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2021-08-06

Official Correspondent

Konstantinos Spartiotis

US Agent Details

Robert Sachs Business: Freedom Technologies Group LLC Email: drsachs@ftgimaging.com Phone: (248) 7605611

Related Public Records

Same Entity

Athlos Oy

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

Similar Registrations

Registration Number	Establishment Name	Location
3011326671	STERI-SHIELD INCORPORATED	Fernandina Beach, FL, US
3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3015509619	DURR DENTAL SE	Bietigheim-Bissingen Baden-Wurttemberg, DE
3011944170	ZAPALIGN INC.	Anyang-si Gyeonggi, KR
3016170492	SHANGHAI ALWINGS MEDICAL INSTRUMENT CO.,LTD.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020117925. Last updated year: 2026. Please use registration number 3020117925 when referencing this establishment in official correspondence.