Manufacturer registered with FDA
Forestadent Bernhard Forster GmbH
PFORZHEIM, Germany. Lists 16 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 16
- Brands and models
- 26
- 510(k) clearances
- 41993–2011
- Markets registered in
- 561 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 1990–2026
Registered in 5 markets
Where regulators' registries name Forestadent Bernhard Forster GmbH 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 | Forestadent Bernhard Forster GmbH | 4 clearances | 1993–2011 | Below |
| South Korea | MFDS | Manufacturer | FORESTADENT Bernhard Forster GmbHFORESTADENT BERNHARD FORSTER GMBH. · FORESTADENT (Bernhard Forster GmbH) · +1 | 35 | 1999–2012 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Forestadent Bernhard Förster GmbH | 24 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | FORESTADENT BERNHARD FORSTER GMBH | 1 | 2017–2017 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Forestadent Bernhard Förster GmbH | 1 | 2018–2018 | 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 Forestadent Bernhard Forster GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Orthodontic Expansion ScrewOrthodontic RetainerOrthoEasy PalOrthoEasy Pal Long Neck | 1992 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | QuicKlear -BracketsTruKlear Brackets | 2009 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | Ortho Easy PinOrthoEasy PalOrthoEasy Pal Long Neck | 2011 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic wires and arch wires | 1992 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Flat- Line Buccal Tubes | 1992 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Ortho Easy Accessories | 2011 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Molar Bands | 1992 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | CLAMP WIRE | 2005 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Spring | 1992 |
| Preformed ClaspEHP · Class 1 | — | Maker | CLASPPreformed wire accessories | 2005 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic Metal Brackets | 1992 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic Pliers and Instruments | 1992 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | Facebow | 1992 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | — | 2023 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Orthodontic teeth positioner | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | OrthoEasy -RackOrthoEasy AccessoriesOrthoEasy bladeOrthoEasy handle for screw driverOrthoEasy pilot drill | 2011 |
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 Forestadent Bernhard Forster GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Jun 2011 | K110275 | ORTHO EASY PIN | OAT Orthodontic Endosseous Implant |
| 5 Jun 2009 | K090933 | BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS | NJM Orthodontic Ceramic Bracket |
| 18 Jun 1993 | K925240 | FACEBOW | DZB Orthodontic Extraoral Headgear |
| 27 May 1993 | K924971 | FORESTADENT BRACKETS | EJF Orthodontic Metal Bracket |
Some of these clearances are listed with FDA today by another company: Aditek do Brasil SA (1).
Also lists devices cleared under other names
Forestadent Bernhard Forster GmbH 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: Bernhard Förster GmbH (Bernhard Foerster Ltd.) (1), Ajw Technology Consultants, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 May 2026 | K260268 | OrthoEasy Pal; OrthoEasy Pal Long Neck | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | OAT Orthodontic Endosseous Implant |
| 25 Jun 2014 | K141104 | TRUKLEAR BRACKET | Ajw Technology Consultants, Inc. | NJM Orthodontic Ceramic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FORESTADENT BERNHARD FORSTER GMBHFDA reg. 8044058 | PFORZHEIM Baden-Wurttemberg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9005337). 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.