Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010159

FEI Number

1000390051

Entity Name

A. SCHWEICKHARDT GMBH & CO. KG

City/State/Country

Seitingen-Oberflacht Baden-Wurttemberg, DE

Establishment Address

Tuttlinger Str. 12, Seitingen-Oberflacht Baden-Wurttemberg D-78606, DE

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

ADOLF SCHWEICKHARDT GMBH & CO. KG (Owner Number: 8010159)

Owner / Operator Contact Address

Tuttlinger Str. 12, --, Seitingen-Oberflacht, DE-NOTA D-78606, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PERIOSTAL ELEVATORS PERIODONTAL FILE NEEDLE-HOLDER ROOT CANAL PLUGGERS ACCESSORIES, IMPLANT RUBBERDAM CLAMP FORCEPS ROOT ELEVATORS G 40-0190 G 40-0194 EXTRACTING FORCEPS CURETTES WIRE CUTTING PLIERS SCISSORS, SURGICAL TISSUE, DENTAL HOE-TYPE SCALERS MOUTH-GAG CHISELS AMALGAM CARRIER TRAY, SURGICAL, INSTRUMENT PROBES FOR DENTAL SURGERY SETTER, BAND, ORTHODONTIC INSTRUMENT, HAND, CALCULUS REMOVAL CALIBRATED PROBE INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC MATRIX RETAINER RETRACTOR, ALL TYPES FORCEPS, DRESSING, DENTAL ORTHODONTIC PLIERS ROOT CANAL SPREADER MALLET COLLAR AND CROWN SCISSORS INSTRUMENTS, DENTAL HAND GUM PUNCH BONE CURETTE HEMOSTATIC FORCEPS GUM KNIVES PUSHER, BAND, ORTHODONTIC GINGIVECTOMY KNIVES CUP, PROPHYLAXIS EXCAVATOR, DENTAL, OPERATIVE RONGEUR FORCEPS OR RONGEURS SCALER, PERIODONTIC HANDLES FOR MIRRORS BROACH HOLDERS HANDLES FOR PROBES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	1977-12-23
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1977-12-23
EMR	File, Periodontic	Dental	Class 1	872.4565	1977-12-23
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1977-12-23
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	1977-12-23
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2004-10-15
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	1977-12-23
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	1977-12-23
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	1977-12-23
EKE	Curette, Operative	Dental	Class 1	872.4565	1977-12-23
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	1977-12-23
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	1977-12-23
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-05-07
EMQ	Hoe, Periodontic	Dental	Class 1	872.4565	1977-12-23
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	1977-12-23
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	1977-12-23
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-10-19
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	1977-12-23
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	1977-12-23
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-17
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	1977-12-23
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	1977-12-23
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	1977-12-23
EIS	Remover, Crown	Dental	Class 1	872.4565	1977-12-23
EIX	Probe, Periodontic	Dental	Class 1	872.4565	1977-12-23
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	1977-12-23
JEP	Retainer, Matrix	Dental	Class 1	872.4565	1977-12-23
EIG	Retractor, All Types	Dental	Class 1	872.4565	1977-12-23
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	1977-12-23
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	1977-12-23
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	1977-12-23
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	1977-12-23
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	1977-12-23
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	1977-12-23
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	1977-12-23
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	1977-12-23
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	1977-12-23
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	1977-12-23
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	1977-12-23
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2013-01-17
EMO	Knife, Periodontic	Dental	Class 1	872.4565	1977-12-23
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2013-05-17
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	1977-12-23
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1977-12-23
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	1977-12-23
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	1977-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

ADOLF SCHWEICKHARDT GMBH & CO. KG

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
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
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 8010159. Last updated year: 2026. Please use registration number 8010159 when referencing this establishment in official correspondence.