Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003794907

FEI Number

3003794907

Entity Name

NEW STETIC

City/State/Country

GUARNE Antioquia, CO

Establishment Address

CARRERA 53, NO. 50-09, GUARNE Antioquia --, CO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NEW STETIC (Owner Number: 9026802)

Owner / Operator Contact Address

CARRERA 53, NO. 50-09, Guarne, CO-ANT 054050, CO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K254245

PMA Number

N/A

All Registered Proprietary Names

Portux 3D Printing Resin SG Portux 3D Printing Resin Cast Portux 3D Printing Resin Basic Portux 3D Printing Resin Model Nordent Super C Reflection Colossus Splendid Fidelity Olympic Plus Newcryl V Newcryl Biodent T-Real BabyDent SteinVit Coral Olympic Duratone-n Ultradent Alfa-Lux Tiziano Portux 3D Printing Resin Try-In Zafira

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2025-04-30
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2025-04-30
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2025-04-30
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2008-05-23
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2025-04-30
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-06-12

Official Correspondent

No official correspondent registered.

US Agent Details

Chris Brown Business: Aclivi, LLC Email: acliviconsulting@gmail.com Phone: (810) 3609773

Related Public Records

Same Entity

NEW STETIC

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
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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01

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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3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3017896270	EXCELLENT PRECISION TECHNOLOGY (DONGGUAN) CO., LTD	Dongguan Guangdong, CN
3042200066	HUB BIOTECH CO., LTD.	BUCHEON-SI Gyeonggi, KR
3042852773	COVISION CO., LTD.	Incheon, KR
3009847764	GMI DENTAL IMPLANTOLOGY, S.L.	Lleida Lerida, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003794907. Last updated year: 2026. Please use registration number 3003794907 when referencing this establishment in official correspondence.