Data / Medical devices / Andorra / Soadco, S.L.

Soadco, S.L.: FDA-registered device maker in Escaldes-Engordany, Andorra, 10 510(k) clearances

Name: Soadco, S.L. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Soadco, S.L. is registered with the FDA (registration 9617542) in Escaldes-Engordany, Andorra. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 18, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9617542
FEI number: 3003267134
Address: AV. DEL PESSEBRE, 76-82 Planta baixa, Escaldes-Engordany, Andorra, AD-700
Owner or operator: SOADCO, S.L. (9044378)
Roles: Manufacturer
First device listed: May 25, 2004
Registered through: 2026
Brand names listed: Essential Cone (EC), Essential ECK, Essential Solid (ES), KLOCKNER ABUTMENTS, KLOCKNER DENTAL IMPLANT S3, KLOCKNER DENTAL IMPLANTS S3M FAMIL, KLOCKNER KITS, Klockner Dental Implant Abutments and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 18, 2024	K243128	Klockner Kits	KCT	Substantially Equivalent	SOADCO, S.L.	accessdata.fda.gov
April 24, 2023	K230103	Klockner Abutments	NHA	Substantially Equivalent	SOADCO, S.L.	accessdata.fda.gov
October 2, 2018	K173642	KLOCKNER SURGICAL BOX	KCT	Substantially Equivalent	SOADCO, S.L.	accessdata.fda.gov
November 16, 2017	K170022	Klockner Vega TiBase for CEREC	NHA	Substantially Equivalent	SOADCO, S.L.	accessdata.fda.gov
April 8, 2016	K153098	KLOCKNER VEGA DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	SOADCO, S.L.	accessdata.fda.gov
January 29, 2016	K151194	KLOCKNER DENTAL IMPLANT ABUTMENTS (II)	NHA	Substantially Equivalent	SOADCO, S.L.	accessdata.fda.gov
July 19, 2013	K122988	KLOCKNER DENTAL IMPLANT ABUTMENTS	NHA	Substantially Equivalent	SOADCO, S.L.	accessdata.fda.gov
November 25, 2008	K082200	KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5	DZE	Substantially Equivalent	SOADCO, S.L.	accessdata.fda.gov
July 3, 2008	K080224	KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK	DZE	Substantially Equivalent	SOADCO, S.L.	accessdata.fda.gov
June 4, 2002	K010132	KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4	DZE	Substantially Equivalent	SOADCO, S.L.	accessdata.fda.gov

Compare with other makers

Updated December 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.