Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680026

FEI Number

1000443015

Entity Name

DEN TAG S.R.L.

City/State/Country

MANIAGO, PN. Pordenone, IT

Establishment Address

VIA MANIAGO, 99 ZONA IND., MANIAGO, PN. Pordenone 33085, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DEN TAG S.R.L. (Owner Number: 9006480)

Owner / Operator Contact Address

VIA MANIAGO, 99 ZONA IND., MANIAGO, PN., IT-PN 33085, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DENTAG DENTAG DENTAG DENTAG DenTag srl DENTAG DenTag srl DenTag srl DENTAG DENTAG DEN TAG S.R.L. DENTAG DENTAG DENTAG DENTAG DENTAG DENTAG DENTAG DENTAG DenTag srl DENTAG DenTag srl DENTAG DENTAG DENTAG DENTAG DENTAG DENTAG DENTAG DenTag Srl DENTAG DenTag srl DENTAG DENTAG DENTAG DENTAG DENTAG DENTAG DENTAG DenTag srl DenTag srl DENTAG DENTAG DenTag srl DENTAG DENTAG DenTag srl DenTag srl DenTag srl

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2011-12-07
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2011-12-09
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2011-05-06
EMQ	Hoe, Periodontic	Dental	Class 1	872.4565	2011-12-09
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2011-05-06
EMR	File, Periodontic	Dental	Class 1	872.4565	2011-12-09
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-11-30
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2020-02-06
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2011-12-09
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2011-12-09
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2011-05-06
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2011-12-09
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2011-12-09
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-12-09
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2011-12-07
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2011-12-09
EKE	Curette, Operative	Dental	Class 1	872.4565	2011-12-09
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2011-12-09
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2011-12-09
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-10-17
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2011-12-09
HXR	Spatula, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2012-12-03
EKA	File, Margin Finishing, Operative	Dental	Class 1	872.4565	2011-12-09
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	2011-12-09
EKB	Explorer, Operative	Dental	Class 1	872.4565	2011-12-09
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2011-12-09
EJZ	Knife, Margin Finishing, Operative	Dental	Class 1	872.4565	2011-12-09
EMP	Marker, Periodontic	Dental	Class 1	872.4565	2011-12-09
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-12-09
EMS	Curette, Periodontic	Dental	Class 1	872.4565	1994-05-05
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2011-12-09
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-12-03
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2011-12-09
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2011-12-09
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2011-12-09
EKT	Curette, Endodontic	Dental	Class 1	872.4565	2011-12-09
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2011-12-09
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2011-12-09
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-12-09
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2015-06-11
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-12-03
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2011-12-09
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2011-12-09
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2012-12-03
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2011-12-09
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2011-12-09
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2012-11-30
HXB	Probe	Orthopedic	Class 1	888.4540	2012-12-03
HXG	Tamp	Orthopedic	Class 1	888.4540	2012-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

DEN TAG S.R.L.

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

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 9680026. Last updated year: 2026. Please use registration number 9680026 when referencing this establishment in official correspondence.