Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039397999

FEI Number

3039397999

Entity Name

SCHWEIZER FEINWERKTECHNIK GMBH

City/State/Country

Bad Boll Baden-Wurttemberg, DE

Establishment Address

Reuteweg 4, Bad Boll Baden-Wurttemberg 73087, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Schweizer Feinwerktechnik GmbH (Owner Number: 10093456)

Owner / Operator Contact Address

Reuteweg 4, Bad Boll, DE-BW 73087, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PREFIT10 NBR 3.5 PREFIT10 TSV 3.5 PREFIT14 NBA 4.3/5 PREFIT10 3IC 4.1 PREFIT10 3IC 3.4 PREFIT10 3IC 6 SCREW TSV 3.5/4.5/5.7 PREFIT10 TSV 4.5 PREFIT14 NBA 5.5 PREFIT14 NBR 3.5 PREFIT10 NBA 3.5 SCREW NBR 3.5 PREFIT10 3IC 5 PREFIT10 TSV 5.7 SCREW NBA 3.5 PREFIT10 NBR 4.3 PREFIT14 3IC 5 PREFIT10 NBA 5.5 PREFIT14 TSV 5.7 PREFIT14 NBR 5 PREFIT14 TSV 3.5 PREFIT14 3IC 4.1 PREFIT14 TSV 4.5 PREFIT14 NBR 4.3 PREFIT14 3IC 6 PREFIT10 NBA 4.3/5 PREFIT10 NBR 5 PREFIT14 NBA 3.5 PREFIT14 NBR 6 PREFIT10 NBR 6 SCREW 3IC 3.4/4.1/5/6 SCREW NBR 4.3/5/6 SCREW NBA 4.3/5 PREFIT14 KEP 4.1 PREFIT10 KEX 6.5 PREFIT14 KEP 3.5 PREFIT10 KEP 4.1 PREFIT14 KEP 5 PREFIT10 KEX 5 PREFIT14 KEX 6.5 PREFIT14 KEX 5 SCREW KEP 3.5/4.1/5 PREFIT10 KEP 3.5 PREFIT10 KEP 5 PREFIT14 NGM PREFIT10 BLX RB SCREW STB 2.9 PREFIT14 BLX RB PREFIT10 BLX WB PREFIT10 STS 6.5 SCREW BLX RB/WB PREFIT14 STS 4.8 PREFIT14 STB 3.3 SCREW STB 4.1/4.8 PREFIT14 BLX WB PREFIT14 STS 6.5 SCREW STS 4.8/6.5 SCREW NGM PREFIT10 STB 3.3 SCREW STB 3.3 PREFIT10 STB 4.1/4.8 PREFIT10 NGM PREFIT10 STB 2.9 PREFIT14 STB 4.1/4.8 PREFIT10 STS 4.8

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-06-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-06-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-07

Official Correspondent

Mirjam Edelmann

US Agent Details

Franz Menean Business: Medagent Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

Schweizer Feinwerktechnik 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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

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3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039397999. Last updated year: 2026. Please use registration number 3039397999 when referencing this establishment in official correspondence.