Data / Medical devices / Sweden / Neoss AB

Neoss AB: FDA-registered device maker in Goteborg Vastra Gotaland, Sweden, 19 510(k) clearances

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

Neoss AB is registered with the FDA (registration 3017399129) in Goteborg Vastra Gotaland, Sweden. It lists 13 device types. The FDA files 19 510(k) clearances under its listings, the newest dated May 17, 2022. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3017399129
Address: Arvid Wallgrens Backe 20, Goteborg Vastra Gotaland, Sweden, 41346
Owner or operator: Neoss AB (10077271)
Roles: Exporter to the US, Manufacturer
First device listed: August 19, 2020
Registered through: 2026
Brand names listed: 1- 6mm Locator Abutment for Neoss 4.1mmD Implant, Adjustment handle, Clix Activating Tool, Clix Gold Housiing, Cix Insertion Tool, Clix Insert Kit, Clix Ti Housing Kit, Clix Deactivating T,, Equator, Intra-Oral Scanner, NeoScan, LOCATOR replacement - male Red, male clear, male extralight retention blue, male light retention pink, LOCATOR-male process package assembly, Locator replacement male green, NeoGen Collagen Firm and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Attachment, Precision, All	EGG	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Barrier, Animal Source, Intraoral	NPL	2	Exporter to the US	accessdata.fda.gov
Barrier, Synthetic, Intraoral	NPK	2	Manufacturer	accessdata.fda.gov
Bone Grafting Material, Animal Source	NPM	2	Exporter to the US	accessdata.fda.gov
Handle, Instrument, Dental	EJB	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
Screw, Fixation, Intraosseous	DZL	2	Manufacturer	accessdata.fda.gov
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	NBY	2	Exporter to the US	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Exporter to the US	accessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)	KGN	U	Exporter to the US	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 17, 2022	K211396	Neoss Individual Prosthetics	NHA	Substantially Equivalent	Neoss, Ltd.	accessdata.fda.gov
October 5, 2020	K201561	Membrane Screws and Membrane Tacks	DZL	Substantially Equivalent	Neoss Limited	accessdata.fda.gov
August 22, 2019	K181888	Osstell Beacon	EKX	Substantially Equivalent	Osstell AB	accessdata.fda.gov
February 9, 2017	K162158	Porcine Anorganic Bone Mineral in Delivery Applicator	NPM	Substantially Equivalent	Collagen Matrix, Inc.	accessdata.fda.gov
June 23, 2016	K152600	Collagen Dental Wound Dressings	KGN	Substantially Equivalent	Collagen Matrix, Inc.	accessdata.fda.gov
January 7, 2016	K143445	Tellos ISQ Buddy	EKX	Substantially Equivalent	Tellos Medical AB	accessdata.fda.gov
October 8, 2015	K150669	Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)	NHA	Substantially Equivalent	Neoss, Ltd.	accessdata.fda.gov
April 13, 2015	K143327	Neoss Ti Reinforced Membrane	NPK	Substantially Equivalent	Neoss, Ltd.	accessdata.fda.gov
November 5, 2014	K141909	COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP	NPL	Substantially Equivalent	Collagen Matrix, Inc.	accessdata.fda.gov
July 16, 2014	K140714	PORCINE ANORGANIC BONE MINERAL	NPM	Substantially Equivalent	Collagen Matrix, Inc.	accessdata.fda.gov
February 12, 2014	K132464	PTFE SURGICAL SUTURE	NBY	Substantially Equivalent	Omnia Spa	accessdata.fda.gov
September 5, 2012	K113376	NEOSS PROACTIVE TAPERED IMPLANT	DZE	Substantially Equivalent	Neoss, Ltd.	accessdata.fda.gov
August 11, 2010	K100156	COLLAGEN DENTAL MEMBRANE V	NPL	Substantially Equivalent	Collagen Matrix, Inc.	accessdata.fda.gov
May 22, 2009	K090452	NEOSS IMPLANT SYSTEM 03.25	DZE	Substantially Equivalent	Neoss, Ltd.	accessdata.fda.gov
March 2, 2009	K081851	NEOSS ACCESS ABUTMENTS	NHA	Substantially Equivalent	Neoss, Ltd.	accessdata.fda.gov
February 11, 2009	K083561	NEOSS PROACTIVE IMPLANT	DZE	Substantially Equivalent	Neoss, Ltd.	accessdata.fda.gov
December 3, 2007	K072878	MODIFICATION TO: LOCATOR IMPLANT ANCHOR	NHA	Substantially Equivalent	Zest Anchors, Inc.	accessdata.fda.gov
October 19, 2007	K071838	NEOSS VARIOUS TITANIUM ABUTMENTS	NHA	Substantially Equivalent	Neoss, Ltd.	accessdata.fda.gov
March 7, 2005	K043195	NEO IMPLANT SYSTEM	DZE	Substantially Equivalent	Neoss, Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 17, 2022. 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.