Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010245461

FEI Number

3010245461

Entity Name

MAQUIRA INDUSTRIA DE PRODUTOS ODONTOLOGICOS

City/State/Country

Maringa Parana, BR

Establishment Address

Av. Melvin Jones, 773, Maringa Parana 87070030, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Maquira Industria de Produtos Odontologicos (Owner Number: 10054997)

Owner / Operator Contact Address

Av. Melvin Jones, 773, Maringá, BR-PR 87070030, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PriZma 3D Bio Ortho IBT PriZma 3D Bio Guide PriZma 3D Bio Try-In SURGICAL ASPIRATOR ODONTOLOGICAL ASPIRATOR WITH BONE COLLECTOR DIAMOND UNIVERSAL AIRON BICARBONATE PriZma 3D Bio Splint Soft PriZma 3D Bio Splint AIRON POLYESTER ABRASIVE STRIPS AIRON STEEL ABRASIVE STRIP Surgical Cement Fill Canal Provisory Temporary Cement PriZma 3D Bio Crown Diamond PriZma 3D Bio Crown Tough PriZma 3D Bio Crown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2024-08-28
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2024-08-28
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2026-04-23
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2017-05-25
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2017-05-25
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2024-08-28
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2024-04-30
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2023-11-30
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2024-08-29

Official Correspondent

Antonio Leme Junior

US Agent Details

Rodrigo Abreu Business: United Regulatory & Logistics LLC Email: rabreu@unitedregulatory.com Phone: (786) 2667900

Related Public Records

Same Entity

Maquira Industria de Produtos Odontologicos

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
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

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

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3008261720	JJGC Industria e Comercio de Materiais Dentarios SA	Curitiba Parana, BR
3005695824	Align Technology de Costa Rica S.R.L	Belen Heredia, CR
1000118628	FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.	Denton, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010245461. Last updated year: 2026. Please use registration number 3010245461 when referencing this establishment in official correspondence.