Data / Medical devices / Germany / Helmut Zepf Medizintechnik GMBH
Helmut Zepf Medizintechnik GMBH: FDA-registered device maker in SEITINGEN Baden-Wurttemberg, Germany, 2 510(k) clearances
Helmut Zepf Medizintechnik GMBH is registered with the FDA (registration 9611367) in SEITINGEN Baden-Wurttemberg, Germany. It lists 96 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 5, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611367
- FEI number
- 3002807169
- Address
- Obere Hauptstr. 16-20, SEITINGEN Baden-Wurttemberg, Germany, D-78606
- Owner or operator
- HELMUT ZEPF MEDIZINTECHNIK GMBH (8010277)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- February 15, 1982
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Manufacturer | accessdata.fda.gov |
| Bar, Preformed | EHO | 1 | Manufacturer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bone Mill | LYS | 1 | Manufacturer | accessdata.fda.gov |
| Brush, Scrub, Operating-Room | GEC | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Burnisher, Operative | EKJ | 1 | Manufacturer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Carrier, Amalgam, Operative | EKI | 1 | Manufacturer | accessdata.fda.gov |
| Carver, Dental Amalgam, Operative | EKH | 1 | Manufacturer | accessdata.fda.gov |
| Carver, Wax, Dental | EIK | 1 | Manufacturer | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Manufacturer | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Manufacturer | accessdata.fda.gov |
| Condenser, Amalgam And Foil, Operative | EKG | 1 | Manufacturer | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Manufacturer | accessdata.fda.gov |
| Curette | HTF | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Endodontic | EKT | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Operative | EKE | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Periodontic | EMS | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Surgical, Dental | EMK | 1 | Manufacturer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Manufacturer | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Driver, Band, Orthodontic | ECT | 1 | Manufacturer | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Contract manufacturer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Contract manufacturer | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Manufacturer | accessdata.fda.gov |
| Excavator, Dental, Operative | EKC | 1 | Manufacturer | accessdata.fda.gov |
| Explorer, Operative | EKB | 1 | Manufacturer | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Manufacturer | accessdata.fda.gov |
| File, Periodontic | EMR | 1 | Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Articulation Paper | EFK | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Contract manufacturer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Rongeur, Surgical | EMH | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Rubber Dam Clamp | EJG | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Manufacturer | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Manufacturer | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Manufacturer | accessdata.fda.gov |
| Hemostat, Surgical | EMD | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Contract manufacturer | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Knife, Margin Finishing, Operative | EJZ | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Periodontic | EMO | 1 | Manufacturer | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Manufacturer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Suturing, Reusable | GDL | 1 | Manufacturer | accessdata.fda.gov |
| Nipper, Malleus | JYR | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Manufacturer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pliers, Operative | EJY | 1 | Manufacturer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Manufacturer | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Manufacturer | accessdata.fda.gov |
| Probe | HXB | 1 | Manufacturer | accessdata.fda.gov |
| Probe, Periodontic | EIX | 1 | Manufacturer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Manufacturer | accessdata.fda.gov |
| Pusher, Band, Orthodontic | ECS | 1 | Manufacturer | accessdata.fda.gov |
| Remover, Crown | EIS | 1 | Manufacturer | accessdata.fda.gov |
| Retainer, Matrix | JEP | 1 | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, Vaginal | HDL | 1 | Manufacturer | accessdata.fda.gov |
| Saw, Manual And Accessories | GDR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, Collar And Crown | EIR | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Intraosseous | DZL | 2 | Manufacturer | accessdata.fda.gov |
| Setter, Band, Orthodontic | ECR | 1 | Manufacturer | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Manufacturer | accessdata.fda.gov |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | 1 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
| Trephine | HWK | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tonsil Suction | KCB | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Manufacturer | accessdata.fda.gov |
| Wrench | HXC | 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 |
|---|
| July 5, 2013 | K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Ermis Medizintechnik | accessdata.fda.gov |
| December 29, 2009 | K092855 | MILTEX MEMBRANE TACK KIT | DZL | Substantially Equivalent | Miltex, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 5, 2013. 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.