Manufacturer registered with FDA
Medartis AG
BASEL, Switzerland. Lists 4 dental device types with FDA across 2 registered establishments, and holds 6 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 9
- 510(k) clearances
- 61999–2007
- Markets registered in
- 14646 registrations outside the US
- Establishments
- 2Switzerland, United States
510(k) clearances per year, 1990–2026
Registered in 14 markets
Where regulators' registries name Medartis AG 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 | Medartis AG | 6 clearances | 1999–2007 | Below |
| Saudi Arabia | SFDA | Manufacturer | Medartis AG | 400 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Medartis AG | 47 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MEDARTIS AG | 42 | 2006–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Medartis AG | 36 | 2023–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Medartis AG | 32 | 2007–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | MEDARTIS A.G.Medartis AG | 29 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Medartis AG | 20 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Medartis AG | 12 | 2018–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MEDARTIS AG | 8 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MEDARTIS AG | 6 | 2023–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | MEDARTIS AGMedartis AG | 6 | 2010–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | MEDARTIS AG | 4 | 2000–2000 | Pure Global AI |
| Israel | AMAR | Manufacturer | Medartis AG | 4 | — | 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 Medartis AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | MODUS 2.5 Mandibular Reconstruction SystemMODUS Sagittal Split Plate and SliderMODUS Titanium Ostheosynthesis SystemMODUS TriLock 2/2.3/2.5 | 2010 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Titanium Arch BarTTS Tooth SplintTTS-Titanium Trauma Splint | 2012 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | MODUS IMF Screws 2 | 2006 |
| External Mandibular Fixator and/or DistractorMQN · Class 2 | Maxillofacial plates & screws | Maker | MODUS Modular Distraction Osteogenesis System | 2006 |
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 Medartis AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Sep 2007 | K071612 | MODUS TRILOCK 2.0/2.3/2.5 | JEY Bone Plate |
| 21 Oct 2005 | K052061 | MODUS IMF SCREWS 2.0 | DZE Root-Form Endosseous Implant |
| 22 Aug 2005 | K051946 | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM | MQN External Mandibular Fixator and/or Distractor |
| 5 May 2005 | K050934 | MODUS TITANIUM OSTEOSYNTHESIS SYSTEM | JEY Bone Plate |
| 24 Nov 1999 | K992683 | MODUS 2.5 MANDIBULAR TRAUMA SET | JEY Bone Plate |
| 24 Nov 1999 | K992682 | MODUS 2.5 MANDIBULAR RECONSTRUCTION SET | JEY Bone Plate |
Also lists devices cleared under other names
Medartis AG 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: The Straumann Co. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Dec 1999 | K993862 | MODUS SAGITTAL SPLIT PLATE | The Straumann Co. | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDARTIS AGFDA reg. 3003236702 | BASEL Basel-Stadt, Switzerland | Manufacturer |
| Medartis Inc.FDA reg. 3009540749 | Warsaw, IN, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9033581). 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.