Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018662547

FEI Number

3018662547

Entity Name

D.S.P. INDUSTRIAL EIRELI EPP

City/State/Country

Campo Largo Parana, BR

Establishment Address

Streat Marechal Floriano Peixoto 303, Ouro Verde II Brazil, Campo Largo Parana 83606290, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

D.S.P. Industrial EIRELI EPP (Owner Number: 10082658)

Owner / Operator Contact Address

Streat Marechal Floriano Peixoto 303, Ouro Verde II Brazil, Campo Pargo, BR-PR 83606290, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DSP POLISHING PASTE AL - ONE - TWO DSP DIAMOND POLISHING DSP POLISHING PASTE AL - RESTORATION Academic Prosthetic Kit Case Screw Extractor Kit Case Screw Extractor Conical Mini Pilar Fitplus Drivers Kit Case Drivers Twist Drills To Stopper Kit Case Implant Drivers HANDLE / HIL / HIM / HIS Long Ratchet Implant Drivers CMI / FMC / HEB / HIL / HIM / HIS/ Ti HEX Medium Screw Drivers Conisystem Surgical Kit Case Short Ratchet Implant Drivers CMI / FMC / HIL / HIM / HIS / Ti HEX Fitplus Hand Screw Drivers Gingival Height Checkers CM / CMF / CMH / HE / HIL / HIM / HIS Dental Tools PRF Instruments Zygomatic Bicortical Probe Wrenchs Drill Stopper Kit Case Drill Bits CMI Instruments Master Conical Densifiers Kit Case HIS / HIL Academic Prosthetic Kit Cylindrical Densifiers Kit Case Conical Tools Fitguide Instruments Screw Taps Drivers FC / FCM / HE / HEZ Screw Extractors CMH / CMI / FC / FCM / HE / HIM / HIS / HIL Drill Stoppers Fitplus Screwdrivers For Torque Wrench Work Surgical Kit Case Conical Drills Kits Zygomatic Kit Driver Handle Screwdrivers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2023-08-22
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2023-06-29

Official Correspondent

No official correspondent registered.

US Agent Details

PASSARINI CRO AND REGULATORY SOLUTIONS LLC Email: usagent@passarini.com.br Phone: (786) 8496760

Related Public Records

Same Entity

D.S.P. Industrial EIRELI EPP

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
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06

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.

Similar Registrations

Registration Number	Establishment Name	Location
3010864832	3D DENTAL DESINGS AND DEVELOPMENT	Shaker Heights, OH, US
9613375	COLTENE/WHALEDENT AG	ALTSTAETTEN Sankt Gallen, CH
9616065	MANUFACTURERA DENTAL CONTINENTAL	ZAPOPAN Jalisco, MX
3004096429	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.	NYON Vaud, CH
3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018662547. Last updated year: 2026. Please use registration number 3018662547 when referencing this establishment in official correspondence.