Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043554

FEI Number

3001000014

Entity Name

STORZ AM MARK GMBH

City/State/Country

EMMINGEN-LIPTINGEN Baden-Wurttemberg, DE

Establishment Address

EMMINGER STR. 39, EMMINGEN-LIPTINGEN Baden-Wurttemberg 78576, DE

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

STORZ AM MARK GMBH (Owner Number: 9002328)

Owner / Operator Contact Address

EMMINGER STR. 39, --, EMMINGEN-LIPTINGEN, DE-BW 78576, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Scaler 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 Gauge Chisel Trephine Drill bit Tissue punch Pilot drill Curette Forceps Tweezers Burnisher Wound Spatula 1001120 / ISHS 1001100 / ISHRC 1001003 / 260-801-056 1001002 / 260-801-055 1001004 / 260-801-002 1001001 / 260-801-165 Explorer Applicator Plugger Cleoid discoid Probe Cement spatula Bone block forceps Wax knife Fistula probe Modelling instrument Amalgam carver Curette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2005-11-30
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2005-11-30
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2005-11-30
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	2005-11-30
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2005-11-30
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2005-11-30
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2005-11-30
EMQ	Hoe, Periodontic	Dental	Class 1	872.4565	2005-11-30
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2010-11-12
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2007-08-09
EMR	File, Periodontic	Dental	Class 1	872.4565	2005-11-30
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2005-11-30
EJY	Pliers, Operative	Dental	Class 1	872.4565	1999-09-21
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2014-10-30
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	1999-09-21
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	2007-08-09
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	1999-09-21
EMP	Marker, Periodontic	Dental	Class 1	872.4565	2005-11-30
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	1999-09-21
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2005-11-30
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2005-11-30
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2005-11-30
EMS	Curette, Periodontic	Dental	Class 1	872.4565	2005-11-30
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	1999-09-21
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2006-11-08
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-08-09
EKE	Curette, Operative	Dental	Class 1	872.4565	2005-11-30
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2005-11-30
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2016-10-18
EIG	Retractor, All Types	Dental	Class 1	872.4565	2005-11-30
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2006-03-06
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2005-11-30
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2005-11-30
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2005-11-30
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2017-11-14
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2005-11-30
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2005-01-04
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	1999-09-21
EIS	Remover, Crown	Dental	Class 1	872.4565	2005-11-30
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2005-11-30
EJL	Bur, Dental	Dental	Class 1	872.3240	2004-09-03
EKT	Curette, Endodontic	Dental	Class 1	872.4565	2005-11-30
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2005-11-30
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2005-11-30
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1999-09-21
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2016-10-18
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2005-11-30
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2005-11-30
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2005-11-30

Official Correspondent

Emmaculate Nih Ndasi

US Agent Details

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

Related Public Records

Same Entity

STORZ AM MARK 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
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043554. Last updated year: 2026. Please use registration number 8043554 when referencing this establishment in official correspondence.