HELMUT ZEPF MEDIZINTECHNIK GMBH

FDA Device Registration & Listing · SEITINGEN Baden-Wurttemberg, DE · Registration 9611367

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9611367
FEI Number
3002807169
Entity Name
HELMUT ZEPF MEDIZINTECHNIK GMBH
City/State/Country
SEITINGEN Baden-Wurttemberg, DE
Establishment Address
OBERE HAUPTSTR. 16-20, SEITINGEN Baden-Wurttemberg D-78606, DE
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
HELMUT ZEPF MEDIZINTECHNIK GMBH (Owner Number: 8010277)
Owner / Operator Contact Address
OBERE HAUPTSTR. 16-20, --, SEITINGEN, DE-NOTA D-78606, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K123234
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EIS Remover, Crown Dental Class 1 872.4565 1996-05-29
JYR Nipper, Malleus Ear, Nose, Throat Class 1 874.4420 1992-09-29
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2013-01-30
JEP Retainer, Matrix Dental Class 1 872.4565 2011-11-08
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 1989-09-08
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2013-02-28
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-01-12
HXB Probe Orthopedic Class 1 888.4540 1997-10-27
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 1997-10-27
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2013-01-08
HWJ Awl Orthopedic Class 1 888.4540 1997-06-19
EMD Hemostat, Surgical Dental Class 1 872.4565 2013-01-31
EIK Carver, Wax, Dental Dental Class 1 872.4565 1989-09-08
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 1997-10-27
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 1996-05-29
EML Chisel, Bone, Surgical Dental Class 1 872.4565 1989-09-08
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2017-01-12
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2013-01-30
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2013-11-18
GAD Retractor General, Plastic Surgery Class 1 878.4800 2013-01-08
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 1996-05-29
EMK Curette, Surgical, Dental Dental Class 1 872.4565 1996-05-29
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2013-01-08
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1989-05-23
EIX Probe, Periodontic Dental Class 1 872.4565 1997-10-27
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2013-07-19
DZC Wire, Orthodontic Dental Class 1 872.5410 2001-10-23
EKT Curette, Endodontic Dental Class 1 872.4565 2017-01-12
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 1997-06-19
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2013-02-28
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 1997-06-19
KTZ Caliper Orthopedic Class 1 888.4150 2013-01-30
DZN Instruments, Dental Hand Dental Class 1 872.4565 2013-01-31
EJL Bur, Dental Dental Class 1 872.3240 1998-09-04
EIR Scissors, Collar And Crown Dental Class 1 872.4565 1996-05-29
HTD Forceps General, Plastic Surgery Class 1 878.4800 2012-12-18
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 1996-06-05
EHK Cup, Prophylaxis Dental Class 1 872.6290 2011-09-06
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2011-11-05
HXC Wrench Orthopedic Class 1 888.4540 2004-10-20
EKE Curette, Operative Dental Class 1 872.4565 2013-01-31
ECM Band, Preformed, Orthodontic Dental Class 1 872.5410 1989-09-08
EHO Bar, Preformed Dental Class 1 872.3165 1992-09-29
EAX Mirror, Mouth Dental Class 1 872.4565 1997-10-27
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2013-01-30
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2012-12-17
EMO Knife, Periodontic Dental Class 1 872.4565 2012-12-18
EMI File, Bone, Surgical Dental Class 1 872.4565 1989-09-08
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2013-01-08
HTF Curette General, Plastic Surgery Class 1 878.4800 1996-05-29
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 1989-09-08
EKG Condenser, Amalgam And Foil, Operative Dental Class 1 872.4565 1989-09-08
EKC Excavator, Dental, Operative Dental Class 1 872.4565 1996-05-29
EKH Carver, Dental Amalgam, Operative Dental Class 1 872.4565 1989-09-08
EJZ Knife, Margin Finishing, Operative Dental Class 1 872.4565 2013-01-31
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 1989-09-08
EKI Carrier, Amalgam, Operative Dental Class 1 872.4565 1989-09-08
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 1992-09-29
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-01-30
EJB Handle, Instrument, Dental Dental Class 1 872.4565 1997-06-19
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 1988-12-27
ECR Setter, Band, Orthodontic Dental Class 1 872.4565 1989-09-08
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2013-01-08
EFK Forceps, Articulation Paper Dental Class 1 872.4565 1989-09-08
ECT Driver, Band, Orthodontic Dental Class 1 872.4565 1989-09-08
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2013-01-31
EJG Forceps, Rubber Dam Clamp Dental Class 1 872.6300 1989-09-08
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 2001-08-02
EMR File, Periodontic Dental Class 1 872.4565 1997-10-27
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 1992-09-29
EIG Retractor, All Types Dental Class 1 872.4565 1996-05-29
LYS Bone Mill Orthopedic Class 1 888.4540 2012-12-17
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2014-07-21

Official Correspondent

PATRICK ZEPF

US Agent Details

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

Related Public Records

Same Entity

HELMUT ZEPF MEDIZINTECHNIK 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
K831136 Almore Intl., Inc. DOUBLE BOW TOOTH SEPARATOR 1983-06-08
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19
K820290 The Anspach Effort, Inc. SELF RETAINING RETRACTOR FOR HAND SURG 1982-03-05
K760422 Cutter Laboratories, Inc. SURGICAL RETRACTOR 1976-08-23
K112640 Ormco Corp. HYPERELASTIC WIRE 2011-11-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011 Depuy Orthopaedics, Inc. 1
Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611367. Last updated year: 2026. Please use registration number 9611367 when referencing this establishment in official correspondence.
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