Data / Medical devices / Germany / Forestadent Bernhard Forster GMBH

Forestadent Bernhard Forster GMBH: FDA-registered device maker in PFORZHEIM Baden-Wurttemberg, Germany, 5 510(k) clearances

Name: Forestadent Bernhard Forster GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Forestadent Bernhard Forster GMBH is registered with the FDA (registration 8044058) in PFORZHEIM Baden-Wurttemberg, Germany. It lists 17 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 19, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8044058
FEI number: 1000185289
Address: 151, Westliche Karl-Friedrich-Str., PFORZHEIM Baden-Wurttemberg, Germany, D-75172
Owner or operator: FORESTADENT BERNHARD FORSTER GMBH (9005337)
Roles: Manufacturer
First device listed: June 4, 1992
Registered through: 2026
Brand names listed: CLAMP WIRE, CLASP, Facebow, Flat- Line Buccal Tubes, Ortho Easy Accessories, Ortho Easy Pin, OrthoEasy -Rack, OrthoEasy Accessories and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Band, Preformed, Orthodontic	ECM	1	Manufacturer	accessdata.fda.gov
Bracket, Ceramic, Orthodontic	NJM	2	Manufacturer	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Manufacturer	accessdata.fda.gov
Clamp, Wire, Orthodontic	ECN	1	Manufacturer	accessdata.fda.gov
Clasp, Preformed	EHP	1	Manufacturer	accessdata.fda.gov
Facebow	KCR	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Orthodontic	OAT	2	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Manufacturer	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Manufacturer	accessdata.fda.gov
Spring, Orthodontic	ECO	1	Manufacturer	accessdata.fda.gov
Tray, Fluoride, Disposable	KMT	1	Manufacturer	accessdata.fda.gov
Tube, Orthodontic	DZD	1	Manufacturer	accessdata.fda.gov
Wire, Orthodontic	DZC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 19, 2026	K260268	OrthoEasy Pal; OrthoEasy Pal Long Neck	OAT	Substantially Equivalent	Bernhard Förster GmbH (Bernhard Foerster Ltd.)	accessdata.fda.gov
August 2, 2024	K241311	Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)	MQC	Substantially Equivalent	Bernhard Förster GmbH	accessdata.fda.gov
June 25, 2014	K141104	TRUKLEAR BRACKET	NJM	Substantially Equivalent	Ajw Technology Consultants, Inc.	accessdata.fda.gov
June 3, 2011	K110275	ORTHO EASY PIN	OAT	Substantially Equivalent	Forestadent Bernhard Forster GmbH	accessdata.fda.gov
June 5, 2009	K090933	BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS	NJM	Substantially Equivalent	Forestadent Bernhard Forster GmbH	accessdata.fda.gov

Compare with other makers

Updated May 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.