Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019252621

FEI Number

3019252621

Entity Name

PREFERRED ORAL DESIGN LIMITADA

City/State/Country

Alajuela, San Rafael, CR

Establishment Address

Potrerillos street Flexipark Industrial park warehouse D2, Alajuela, San Rafael 20101, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Preferred Oral Design Limitada (Owner Number: 10081810)

Owner / Operator Contact Address

Potrerillos street Flexipark Industrial park warehouse D2, Alajuela, San Rafael, CR-A 20101, CR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PFM Abutment, implant, dental, endosseous Accessories, implant, dental, endosseous NHA / Abutment, implant, dental, endosseous Abutment, implant, dental, endosseous Restoration, porcelain Abutment, implant, dental, endosseous Dentures, full Abutment, implant, dental, endosseous Abutment, implant, dental, endosseous Abutment, implant, dental, endosseous Abutment, implant, dental, endosseous Abutment, implant, dental, endosseous CROWN, PREFORMED Straumann CARES M-Series CAD/CAM System Abutment, implant, dental, endosseous

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2021-05-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-06-08
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2021-05-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-05-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-06-08
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2021-06-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-06-08
NSL	Dentures, Full	Unknown	Class N	N/A	2021-05-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-06-08
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-06-08
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-06-08
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-06-08
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-06-08
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2021-05-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-06-08
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2021-06-08
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-06-08

Official Correspondent

Brett Pittman

US Agent Details

Van Bui Business: B2 Solutions, LLC Email: van.bui@evo820.com Phone: (206) 2148570

Related Public Records

Same Entity

Preferred Oral Design Limitada

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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3004764611	MAVERICK DENTAL SOLUTIONS, LLC	Monroeville, PA, US
3013969202	FIRE DENTAL STUDIO, LLC	Westmont, IL, US
3027650644	NORTHSTAR TRADE CO., LIMITED	Mongkok KL Hong Kong, CN
3008193102	V-BEST DENTAL TECHNOLOGY LIMITED	Kwun Tong, HK
3008546433	Oral Design Center	Meguro-Ku Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019252621. Last updated year: 2026. Please use registration number 3019252621 when referencing this establishment in official correspondence.