Manufacturer registered with FDA
Jabil Inc.
Saint Petersburg, FL, United States. Lists 9 dental device types with FDA across 9 registered establishments.
- Device types listed
- 9
- Brands and models
- 25
- 510(k) clearances
- 0as applicant
- Markets registered in
- 562 registrations outside the US
- Establishments
- 9Switzerland, Germany, United States
Registered in 5 markets
Where regulators' registries name Jabil Inc. 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 | Jabil Inc. | 9 device types | — | Below |
| South Korea | MFDS | Manufacturer | Jabil Tuttlingen Manufacturing GmbHJABIL TUTTLINGEN MANUFACTURING GMBH | 40 | 2005–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Jabil Inc.JABIL, INC. | 11 | 2002–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | JABIL, INCJABIL TUTTLINGEN MANUFACTURING GMBH · JABIL INC. | 10 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | JABIL TUTTLINGEN MANUFACTURING GMBH | 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 Jabil Inc. 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 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)DePuy Synthes Maxillofacial Portfolio - MR ConditionalPlateSYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORSynthes MatrixMANDIBLE Preformed ReSynthes MatrixMANDIBLE Preformed Reconstruction PlatesSynthes Neuro Plate and Screw Syste | 2019 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | DePuy Synthes Maxillofacial Portfolio - MR ConditionalSYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORSYNTHES TITANIUM MULTI-VECTOR DISTRACTOR | 2019 |
| External Mandibular Fixator and/or DistractorMQN · Class 2 | Maxillofacial plates & screws | Maker | CMFD MandibleDePuy Synthes Maxillofacial Portfolio - MR ConditionalMANDIBLE EXTERNAL FIXATORMINI LENGTHENING APPARATUSSYNTHES (USA) ALVEOLAR RIDGE DISTRASynthes Curvilinear Distraction System | 2019 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes 90 Degree Screwdriver | 2019 |
| Temporary Mandibular Condyle ProsthesisNEI · Class 2 | — | Maker | Condylar Head Add-on-SystemDePuy Synthes Maxillofacial Portfolio - MR ConditionalLOCKING RECONSTRUCTIONSYNTHES (USA) CONDYLAR HEAD ADD-ON | 2019 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | DePuy Synthes Maxillofacial Portfolio - MR Conditional | 2019 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | — | 2019 |
| Intraosseous Fixation WireDZK · Class 2 | — | Maker | DePuy Synthes Maxillofacial Portfolio - MR Conditional | 2024 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | chisel | 2019 |
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 |
|---|---|---|
| Jabil Inc. (Brandywine)FDA reg. 3015212339 | W Chester, PA, United States | Contract manufacturer |
| Jabil Inc. (Elmira)FDA reg. 3015440604 | Horseheads, NY, United States | Contract manufacturer |
| Jabil Inc. (Monument)FDA reg. 3015399803 | Monument, CO, United States | Contract manufacturer |
| Jabil Switzerland Manufacturing GmbH (Balsthal)FDA reg. 3015877656 | Balsthal Solothurn, Switzerland | Contract manufacturer |
| Jabil Switzerland Manufacturing GmbH (Bettlach)FDA reg. 3015882686 | Bettlach Solothurn, Switzerland | Contract manufacturer |
| Jabil Switzerland Manufacturing GmbH (Hagendorf)FDA reg. 3015876273 | Hagendorf Solothurn, Switzerland | Contract manufacturer |
| Jabil Switzerland Manufacturing GmbH (Mezzovico)FDA reg. 3015869493 | Mezzovico Ticino, Switzerland | Contract manufacturer |
| Jabil Switzerland Manufacturing GmbH (Raron)FDA reg. 3015869121 | Raron Valais, Switzerland | Contract manufacturer |
| Jabil Tuttlingen Manufacturing GmbHFDA reg. 3017521423 | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer |
Other names on FDA records
Jabil Tuttlingen Manufacturing GmbH · Jabil Inc. (Monument) · Jabil Inc. (Brandywine) · Jabil Inc. (Elmira) · Jabil Switzerland Manufacturing GmbH (Bettlach) · Jabil Switzerland Manufacturing GmbH (Balsthal) · Jabil Switzerland Manufacturing GmbH (Hagendorf) · Jabil Switzerland Manufacturing GmbH (Raron) · Jabil Switzerland Manufacturing GmbH (Mezzovico)
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9074019). 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.