Registered with FDA
Swann Morton Limited
SHEFFIELD, United Kingdom. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 132
- 510(k) clearances
- 0as applicant
- Markets registered in
- 16161 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 16 markets
Where regulators' registries name Swann Morton Limited as the manufacturer or the registration holder of a device.
RegisteredHome: United KingdomOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Swann Morton Limited | 6 device types | — | Below |
| Canada | Health Canada | Registration holder | SWANN MORTON LIMITED | 52 | 1999–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Swann-Morton Ltd | 27 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Swann-Morton Ltd | 23 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Swann-Morton Limited | 12 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Swann-Morton Limited | 9 | 2021–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SWANN - MORTON LIMITEDSWANN-MORTON LIMITED · SWANN-MORTON LTD. · +1 | 9 | 2008–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Swann Morton Limited | 6 | 2004–2017 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Swann Morton Ltd.SWANN-MORTON LIMITED | 5 | 2000–2016 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SWANN MORTON LIMITEDSWANN-MORTON LIMITED | 4 | 2012–2016 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Swann-Morton Ltd.SWANN-MORTON LTD. | 4 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | SWANN-MORTON LTD.SWANN-MORTON LTD | 3 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Swann-Morton Limited | 3 | 2025–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Swann Morton Ltd.Swann-Morton Limited | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 斯旺-摩通Swann-Morton Limited | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SWANN-MORTON LIMITED | 1 | 2019–2019 | 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 Swann Morton Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Lister | Dental Implant SystemImplant System NeoNeo Implant SystemNeoss Implant System 3.25Neoss Proactive ImplantNeoss Proactive Tapered ImplantProactive Implant | 2012 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Lister | Acess AbutmentsDental Implant SystemNeoss Access AbutmentsNeoss Implant System 3.25Neoss Various Titamum AbutmentsTitanium Abutments | 2012 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Lister | DB10-0001 Infinitas Mini Implant - 1.5mmD, 6mmL, Short Neck, Standard HeadDB10-0002 Infinitas Mini Implant - 1.5mmD, 9mmL, Short Neck, Standard HeadDB10-0004 Infinitas Mini Implant - 1.5mmD, 9mmL, Long Neck, Standard HeadDB10-0007 Infinitas Mini Implant - 2mmD, 6mmL, Long Neck, Standard HeadDB10-0008 Infinitas Mini Implant - 2mmD, 9mmL, Long Neck, Standard HeadDB10-0009 Infinitas Mini Implant - 1.5mmD, 6mmL, Short Neck, Standard HeadDB10-0010 Infinitas Mini Implant - 1.5mmD, 9mmL, Short Neck, Standard HeadDB10-0012 Infinitas Mini Implant - 1.5mmD, 9mmL, Long Neck, Standard HeadDB10-0015 Infinitas Mini Implant - 2mmD, 6mmL, Long Neck, Standard HeadDB10-0016 Infinitas Mini Implant - 2mmD, 9mmL, Long Neck, Standard Head | 2025 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Lister | Membrane Screws and Membrane TacksSCREW, FIXATION, INTAOSSEOUS | 2023 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | 100350 SmartPeg Type 4100353 SmartPeg Type 1100355 SmartPeg Type 2100357 SmartPeg Type 3100359 SmartPeg Type 12100361 SmartPeg Type 13100363 SmartPeg Type A3100366 SmartPeg Type 8100368 SmartPeg Type 9100370 SmartPeg Type 10 95 more100372 SmartPeg Type 11100374 SmartPeg Type 14100376 SmartPeg Type 5100378 SmartPeg Type 6100380 SmartPeg Type 7100386 SmartPeg Type 15100388 SmartPeg Type 16100390 SmartPeg Type 17100398 SmartPeg Type 18100402 SmartPeg Type 21100404 SmartPeg Type 22100411 SmartPeg Type 23100412 SmartPeg Type 24100415 SmartPeg Type 25100425 SmartPeg Type 26100431 SmartPeg Type 27100432 SmartPeg Type 28100436 SmartPeg Type 30100438 SmartPeg Type 31100440 SmartPeg Type 32100442 SmartPeg Type 33100444 SmartPeg Type 34100446 SmartPeg Type 35100447 SmartPeg Type 36100448 SmartPeg Type 37100455 SmartPeg Type 38100462 SmartPeg Type 40100466 SmartPeg Type 44100472 SmartPeg Type 45100477 SmartPeg Type 46100478 SmartPeg Type 47100479 SmartPeg Type 48100480 SmartPeg Type 49100481 SmartPeg Type 50100482 SmartPeg Type 51100483 SmartPeg Type 52100484 SmartPeg Type 53100485 SmartPeg Type 54100487 SmartPeg Type 55100497 SmartPeg Type 57100541 SmartPeg Type 58100543 SmartPeg Type 60100544 SmartPeg Type 61100545 SmartPeg Type 62100554 SmartPeg Type 63100555 SmartPeg Type 64100557 SmartPeg Type 65100558 SmartPeg Type 66100559 SmartPeg Type 67100560 SmartPeg Type 68100561 SmartPeg Type 77100576 SmartPeg Type 69100579 SmartPeg Type 73100580 SmartPeg Type 74100581 SmartPeg Type 75100582 SmartPeg Type 76100583 SmartPeg Type 78100584 SmartPeg Type 79100612 SmartPeg Type 91100634 SmartPeg Type 87100670 SmartPeg Type 80100671 SmartPeg Type 81100674 SmartPeg Type 82100714 SmartPeg Type 83100715 SmartPeg Type 84100716 SmartPeg Type 85100717 SmartPeg Type 86100743 SmartPeg Type 97100744 SmartPeg Type 107100747 SmartPeg Type 88100748 SmartPeg Type 89100749 SmartPeg Type 90100751 SmartPeg Type 92100756 SmartPeg Type 93100757 SmartPeg Type 94100758 SmartPeg Type 95100759 SmartPeg Type 96100764 SmartPeg Type 99100765 SmartPeg Type 100100766 SmartPeg Type 101100767 SmartPeg Type 102100768 SmartPeg Type 103100769 SmartPeg Type 104100770 SmartPeg Type 110100771 SmartPeg Type 111100780 SmartPeg Type 106100781 SmartPeg Type 108100782 SmartPeg Type 109100809 SmartPeg Type 117100810 SmartPeg Type 127100811 SmartPeg Type 13791070 SmartPeg Type 18 - Neoss91071 SmartPeg Type 38 - Neoss91072 SmartPeg Type 52 - Neoss91073 SmartPeg Type 98 - Neoss | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUSNeoss Implant System Instructmets and Accessories | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Swann-Morton(Services) LimitedFDA reg. 3008812251 | Owlerton Green Sheffield, United Kingdom | Contract sterilizer |
Other names on FDA records
Swann-Morton(Services) Limited
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9003320). 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.