FDA Registration
Active
🇩🇪 Germany
STORZ AM MARK GMBH
Reg #: 8043554
·
FEI: 3001000014
·
Expires 2026
Products
66
Proprietary Names
111
Establishment Types
4
Classifications
66
Registration Details
- Registration Name
- STORZ AM MARK GMBH
- Registration Number
- 8043554
- FEI Number
- 3001000014
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- EMMINGER STR. 39
- City
- EMMINGEN-LIPTINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K080430
Owner / Operator
- Firm Name
- STORZ AM MARK GMBH
- Operator Number
- 9002328
- Address
- EMMINGER STR. 39, --
- City
- EMMINGEN-LIPTINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78576
- Country
- DE
- Correspondent
- Emmaculate Nih - Ndasi
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2005-11-30 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2005-11-30 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2005-11-30 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 2005-11-30 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2005-11-30 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2005-11-30 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 2005-11-30 |
| Hoe, Periodontic | EMQ | Class 1 | Dental | No | 2005-11-30 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2010-11-12 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| File, Periodontic | EMR | Class 1 | Dental | No | 2005-11-30 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2005-11-30 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 1999-09-21 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2014-10-30 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 1999-09-21 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 1999-09-21 |
| Marker, Periodontic | EMP | Class 1 | Dental | No | 2005-11-30 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 1999-09-21 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 2005-11-30 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2005-11-30 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 2005-11-30 |
| Curette, Periodontic | EMS | Class 1 | Dental | No | 2005-11-30 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 1999-09-21 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2006-11-08 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Curette, Operative | EKE | Class 1 | Dental | No | 2005-11-30 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2016-10-18 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2005-11-30 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2006-03-06 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2005-11-30 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2005-11-30 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2005-11-30 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2017-11-14 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2005-11-30 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2005-01-04 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 1999-09-21 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2005-11-30 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2005-11-30 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2004-09-03 |
| Curette, Endodontic | EKT | Class 1 | Dental | No | 2005-11-30 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2005-11-30 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 2005-11-30 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 1999-09-21 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2016-10-18 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2005-11-30 |
| Carver, Dental Amalgam, Operative | EKH | Class 1 | Dental | No | 2005-11-30 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2005-11-30 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2013-07-11 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2005-11-30 |
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 1999-09-21 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2005-11-30 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2005-11-30 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2005-11-30 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 1999-09-21 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2016-10-18 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2005-11-30 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2004-12-20 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 2005-11-30 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2005-11-30 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2007-08-09 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2005-11-30 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1999-09-21 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 1999-09-21 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 1999-09-21 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2005-11-30 |
Proprietary Names
Matrix band
Matrix retainer
Bone rongeur forceps
Rongeur
Impression tray
Scaler
Crown scissors
Gauge
Tunnel-instrument
Periotome
Gingivectomy knife
Hoe, periodontic
micro-screw
HEMOSTATIC FORCEPS
Artery forceps
File
Root canal plugger
Pliers
Pilot Drill
File, Bone File, Interdental File
Needles
Mallet, Spare Rubber Jaws for Mallet
Pocket Marking Tweezers
Mouth gag, Mouth prop, cheek retractor
Amalgam carrier
Tongue forceps
Tongue depressor
Tongue spatula
Tissue punch
Scraper
color-stick curette
Curette
Articulating Paper Tweezers
Bone crusher
Needle holder
Scraper, Sharp spoon, Bone scraper
Titanium screw
1001110 / IRC
Hook
Retractor
Measuring Caliper, Ruler, Caliper
Rubber dam clamp forceps
Rubber dam punch
Filling instrument
Burnisher
Spatula
Amalgam applicator
Plugger
Fissure instrument
Composite instrument
1001070 / ISCRS
Scissors
Tissue Scissors
Micro-Scissors
Towel forceps, Dental
color-stick scaler
1001005 / 260-801-001
Tip for contra angled piece
Insert
Screwdriver
Handle for screwdriver
Rubber dam clamp
Crown spreader
Crown butler
Crown remover
Chisel
Trephine
Drill bit
Pilot drill
Forceps
Tweezers
Wound Spatula
1001120 / ISHS
1001100 / ISHRC
1001003 / 260-801-056
1001002 / 260-801-055
1001004 / 260-801-002
1001001 / 260-801-165
Explorer
Applicator
Cleoid discoid
Probe
Cement spatula
Bone block forceps
Wax knife
Fistula probe
Modelling instrument
Amalgam carver
STOMA-Cannula
Luxelevator
Elevator
Cutting Instrument
Periodontometer tip
Periodontal probe
Periodontometer
Extracting forceps
Excavator
Band setter, Ligature Applicator
1001130 / IPSS
Wire forceps, Rubber ring removing forceps, Flat pliers, Round pliers, Pin bending pliers, Wire bending pliers
Osteotome
Wax instrument
Spare cannula for water syringe
Water syringe
Thread removing scissors
Cheek retractor mirror
Mirror
Mouth mirror
p.i.c.-tray, p.i.c.-wash tray, Norm-tray
Stomaform-handel, handle, scalpel-handle, mirror and probe handle, scalpel blade holder, mirror handle, special handle
Spreader
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)