Data / Medical devices / Germany / Hu-Friedy Mfg.co. LLC Zweigniederlassung Deutsc
Hu-Friedy Mfg.co. LLC Zweigniederlassung Deutsc: FDA-registered device maker in Emmingen-Liptingen Baden-Wurttemberg, Germany, 13 510(k) clearances
Hu-Friedy Mfg.co. LLC Zweigniederlassung Deutsc is registered with the FDA (registration 3004193466) in Emmingen-Liptingen Baden-Wurttemberg, Germany. It lists 64 device types. The FDA files 13 510(k) clearances under its listings, the newest dated July 5, 2013. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3004193466
- Address
- Bogenstrasse 6 - 8, Emmingen-Liptingen Baden-Wurttemberg, Germany, 78576
- Owner or operator
- Hu-Friedy Mfg Co., LLC (1416605)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- December 12, 1977
- Registered through
- 2027
- Brand names listed
- AMALGAM AND FOIL, AMALGAM CARVERS, AMALGAM PLUGGERS, After Five, After Five Plus, Cartridge Syringe, DENTAL ELEVATORS, DENTAL EXPLORER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bar, Preformed | EHO | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Burnisher, Operative | EKJ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Carrier, Amalgam, Operative | EKI | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Carrier, Ligature | GEJ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Carver, Dental Amalgam, Operative | EKH | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Clamp | HXD | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Rubber Dam | EEF | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Condenser, Amalgam And Foil, Operative | EKG | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Curette, Periodontic | EMS | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, Dental | EMK | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Excavator, Dental, Operative | EKC | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Explorer, Operative | EKB | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| File, Margin Finishing, Operative | EKA | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| File, Periodontic | EMR | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Articulation Paper | EFK | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Rongeur, Surgical | EMH | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Rubber Dam Clamp | EJG | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Frame, Rubber Dam | EJE | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Hemostat, Surgical | EMD | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Hoe, Periodontic | EMQ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cutting, Operative | EKD | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Knife, Margin Finishing, Operative | EJZ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Knife, Periodontic | EMO | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Mallet | HXL | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Marker, Periodontic | EMP | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Pliers, Operative | EJY | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Probe, Periodontic | EIX | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Pusher, Band, Orthodontic | ECS | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Remover, Crown | EIS | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Collar And Crown | EIR | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Irrigating (Dental) | EIB | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Exporter to the US, Repackager or relabeler | 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 |
| November 6, 2012 | K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | EJI | Substantially Equivalent | Hu-Friedy Mfg. Co., LLC | accessdata.fda.gov |
| March 30, 2010 | K100401 | SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM | ELC | Substantially Equivalent | Hu-Friedy Mfg. Co., Inc. | accessdata.fda.gov |
| July 17, 2007 | K070428 | MEDICOM SELF-SEALING STERILIZATION POUCH | KCT | Substantially Equivalent | A.R. Medicom, Inc. | accessdata.fda.gov |
| June 21, 2007 | K070975 | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES | ELC | Substantially Equivalent | Hu-Friedy Mfg. Co., Inc. | accessdata.fda.gov |
| February 1, 2006 | K053178 | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS | ELC | Substantially Equivalent | Hu-Friedy Mfg. Co., Inc. | accessdata.fda.gov |
| July 27, 2001 | K012060 | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT | ELC | Substantially Equivalent | Hu-Friedy Mfg. Co., Inc. | accessdata.fda.gov |
| October 7, 1995 | K953919 | DENTAL ULTRASONIC SCALER INSERTS | ELC | Substantially Equivalent | Hu-Friedy Mfg. Co., Inc. | accessdata.fda.gov |
| August 7, 1989 | K890755 | SEALING TAPE, STERILIZATION INDICATOR; STEAM | JOJ | Substantially Equivalent | Spsmedical Supply Corp. | accessdata.fda.gov |
| March 31, 1988 | K875193 | INDISTRIP (STERILIZATION PROCESS INDICATOR) | JOJ | Substantially Equivalent | Indilab, Inc. | accessdata.fda.gov |
| November 8, 1984 | K844002 | HU-FRIEDY IMS CASSETTE SYSTEM | FSM | Substantially Equivalent | Hu-Friedy Mfg. Co., Inc. | accessdata.fda.gov |
| June 2, 1983 | K831425 | MDT CHEMITEST SEE-THRU BAG | FRG | Substantially Equivalent | Kenpak Converters, Inc. | accessdata.fda.gov |
| February 13, 1980 | K800123 | DEXTEX II STERILIZATION WRAP | FRG | Substantially Equivalent | Ahlstrom Dexter | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor, All Types
- All makers of Burnisher, Operative
- All makers of Handle, Scalpel
- All makers of Wrap, Sterilization
- All makers of Scaler, Ultrasonic
- All makers of Knife, Periodontic
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.