Data / Medical devices / Italy / Sweden & Martina S.P.A.

Sweden & Martina S.P.A.: FDA-registered device maker in Due Carrare Padova, Italy, 9 510(k) clearances

Name: Sweden & Martina S.P.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sweden & Martina S.P.A. is registered with the FDA (registration 3001082453) in Due Carrare Padova, Italy. It lists 9 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 26, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3001082453
Address: Via Veneto, 10, Due Carrare Padova, Italy, 35020
Owner or operator: SWEDEN & MARTINA S.p.A. (10046682)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: April 28, 2014
Registered through: 2027
Brand names listed: "SURGICAL KIT ""ONEBOX""", "SURGICAL KIT ""ONEBOX2""", 15GR ANGLE PRE-MADE POST, REP., 17GR ANG. EST. PAD ABUT., 17GR ANG. RED. PAD ABUT., 17GR ANGLED PAD ABUT., H3 MM, 17GR ANGLED PAD ABUT., H5 MM, 2-IMPLANT KIT and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
Gutta-Percha	EKM	1	Manufacturer	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Exporter to the US	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Restoration, Resin	NSM	N	Manufacturer	accessdata.fda.gov
Restoration, Resin, Crown And Bridge	NSN	N	Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	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
May 26, 2023	K222640	Sweden & Martina Surgical Trays	KCT	Substantially Equivalent	Sweden & Martina S.P.A.	accessdata.fda.gov
November 4, 2020	K182084	Sweden & Martina Surgical Tray (Model ZSHORTY-INT)	KCT	Substantially Equivalent	Sweden & Martina S.P.A.	accessdata.fda.gov
July 8, 2019	K180365	PRAMA White Implant Systems	DZE	Substantially Equivalent	Sweden & Martina S.P.A.	accessdata.fda.gov
February 1, 2018	K161989	PREMIUM Implant Systems SHELTA Implant Systems	NHA	Substantially Equivalent	Sweden & Martina S.P.A.	accessdata.fda.gov
December 21, 2017	K172560	PREMIUM ONE Implant Systems	DZE	Substantially Equivalent	Sweden & Martina S.P.A.	accessdata.fda.gov
March 24, 2017	K162028	PREMIUM - SHELTA Prosthetic Components	NHA	Substantially Equivalent	Sweden & Martina S.P.A.	accessdata.fda.gov
December 5, 2016	K162004	PREMIUM Implant Systems SHELTA Implant Systems	NHA	Substantially Equivalent	Sweden & Martina S.P.A.	accessdata.fda.gov
February 2, 2015	K142242	PREMIUM, SHELTA Implant Systems	DZE	Substantially Equivalent	Sweden & Martina S.P.A.	accessdata.fda.gov
December 31, 2014	K142124	AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM	EKX	Substantially Equivalent	Aseptico, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 26, 2023. 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.