Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044058

FEI Number

1000185289

Entity Name

FORESTADENT BERNHARD FORSTER GMBH

City/State/Country

PFORZHEIM Baden-Wurttemberg, DE

Establishment Address

151, WESTLICHE, KARL-FRIEDRICH-STR., PFORZHEIM Baden-Wurttemberg D-75172, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FORESTADENT BERNHARD FORSTER GMBH (Owner Number: 9005337)

Owner / Operator Contact Address

151, WESTLICHE, KARL-FRIEDRICH-STR., PFORZHEIM, DE-NOTA D-75172, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141104

PMA Number

N/A

All Registered Proprietary Names

Orthodontic Metal Brackets Orthodontic Spring Orthodontic Pliers and Instruments Orthodontic Retainer Orthodontic Expansion Screw CLASP Preformed wire accessories OrthoEasy Accessories OrthoEasy -Rack OrthoEasy pilot drill OrthoEasy blade OrthoEasy handle for screw driver Flat- Line Buccal Tubes Ortho Easy Accessories Orthodontic teeth positioner Facebow OrthoEasy Pal Long Neck OrthoEasy Pal Ortho Easy Pin Orthodontic Molar Bands CLAMP WIRE QuicKlear -Brackets TruKlear Brackets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	1992-06-04
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	1992-06-04
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	1992-06-04
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	1992-06-04
EHP	Clasp, Preformed	Dental	Class 1	872.3285	2005-07-18
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2011-06-20
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	1992-06-04
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2011-05-10
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2018-11-21
KCR	Facebow	Dental	Class 1	872.3220	1992-06-04
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2026-06-03
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2026-06-03
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2011-06-20
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	1992-06-04
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2005-07-18
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2009-11-17
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2014-12-03

Official Correspondent

MICHAEL FIESS

US Agent Details

Douglas Hurford Business: CFO Email: dhurford@forestadentusa.com Phone: (314) 8785985

Related Public Records

Same Entity

FORESTADENT BERNHARD FORSTER GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K110392	Psm Medical Solutions	PSM LOMAS / BENEFIT SCREWS	2011-12-14
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044058. Last updated year: 2026. Please use registration number 8044058 when referencing this establishment in official correspondence.