Manufacturer registered with FDA
Neoss AB
Goteborg, Sweden. Lists 11 dental device types with FDA across 1 registered establishment, and holds 10 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 13
- 510(k) clearances
- 102005–2022
- Markets registered in
- 9540 registrations outside the US
- Establishments
- 1Sweden
510(k) clearances per year, 2000–2026
Registered in 9 markets
Where regulators' registries name Neoss AB as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Neoss AB | 10 clearances | 2005–2022 | Below |
| Saudi Arabia | SFDA | Manufacturer | Neoss ABNeoss Limited · NEOSS LIMITED | 316 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | NEOSS LTD | 74 | 2015–2015 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Neoss AB | 70 | 2023–2023 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Neoss ABNeoss Ltd | 41 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Neoss AB | 19 | 2005–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Neoss AB | 15 | — | Pure Global AI |
| China | NMPA | Registration holder | 尼奥斯有限公司Neoss AB | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Neoss AB | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Neoss AB currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Neoss Individual Prosthetics1- 6mm Locator Abutment for Neoss 4.1mmD Implant | 2020 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | — | 2020 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | — | 2026 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Lister | NeoGen Collagen FirmNeoGen Collagen Flex | 2026 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Lister | — | 2026 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | — | 2020 |
| All Precision AttachmentEGG · Class 1 | — | Maker | Clix Activating Tool, Clix Gold Housiing, Cix Insertion Tool, Clix Insert Kit, Clix Ti Housing Kit, Clix Deactivating T,EquatorLOCATOR replacement - male Red, male clear, male extralight retention blue, male light retention pinkLOCATOR-male process package assembly, Locator replacement male greenNeoss Implant System Ball Abutment 1-3-4.5-6mm, | 2026 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Adjustment handle | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Neoss Instruments and Accessories, Implant Inserter, Screwdriver, Impression Coping, Replica, Scan Body, ScanPeg,Yomi One Drills, Yomi One Countersinks, Yomi One Instruments and accessories | 2023 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | Intra-Oral Scanner, NeoScan | 2026 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Maker | — | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Neoss AB as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 May 2022 | K211396 | Neoss Individual Prosthetics | NHA Endosseous Dental Implant Abutment |
| 5 Oct 2020 | K201561 | Membrane Screws and Membrane Tacks | DZL Intraosseous Fixation Screw |
| 8 Oct 2015 | K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) | NHA Endosseous Dental Implant Abutment |
| 13 Apr 2015 | K143327 | Neoss Ti Reinforced Membrane | NPK Intraoral Synthetic Barrier |
| 5 Sep 2012 | K113376 | NEOSS PROACTIVE TAPERED IMPLANT | DZE Root-Form Endosseous Implant |
| 22 May 2009 | K090452 | NEOSS IMPLANT SYSTEM 03.25 | DZE Root-Form Endosseous Implant |
| 2 Mar 2009 | K081851 | NEOSS ACCESS ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 11 Feb 2009 | K083561 | NEOSS PROACTIVE IMPLANT | DZE Root-Form Endosseous Implant |
| 19 Oct 2007 | K071838 | NEOSS VARIOUS TITANIUM ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 7 Mar 2005 | K043195 | NEO IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Also lists devices cleared under other names
Neoss AB lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Collagen Matrix, Inc. (4), Osstell AB (1), Tellos Medical AB (1), Zest Anchors, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Aug 2019 | K181888 | Osstell Beacon | Osstell AB | EKX Ac-Powered Direct Drive Handpiece |
| 9 Feb 2017 | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | NPM Animal Source Bone Grafting Material |
| 7 Jan 2016 | K143445 | Tellos ISQ Buddy | Tellos Medical AB | EKX Ac-Powered Direct Drive Handpiece |
| 5 Nov 2014 | K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 16 Jul 2014 | K140714 | PORCINE ANORGANIC BONE MINERAL | Collagen Matrix, Inc. | NPM Animal Source Bone Grafting Material |
| 11 Aug 2010 | K100156 | COLLAGEN DENTAL MEMBRANE V | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 3 Dec 2007 | K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | Zest Anchors, LLC | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NEOSS ABFDA reg. 3017399129 | Goteborg Vastra Gotaland, Sweden | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10077271). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.