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New Stetic, SA

Colombia · Guarne Antioquia

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

13listed device types

Class I 5Class II 7Class III 0unclassified 1

plus 11 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

6active device licences

Class II 6

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States11 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: NEW STETIC · NEW STETIC S.A. · PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S.A.

FDA 510(k) clearances by year

12011 · K102874

12013 · K122925

12014 · K140125

12019 · K192153

12026 · K254245

FDA listed device types

showing 8 of 13

Absorber, Saliva, Paper 1Wax, Dental, Intraoral 1Cotton, Roll 1Accessories, Implant, Dental, Endosseous 1Material, Impression Tray, Resin 1Dental Amalgam 1Alloy, Amalgam 1Resin, Denture, Relining, Repairing, Rebasing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254245	ZAFIRA®	2026-03-03
US	K192153	Portux CAD/CAM Disc	2019-11-07
US	K140125	NEW STETIC DENTAL AMALGAM ALLOY	2014-04-29
BR	81199279033	ACRÍLICO TERMOPOLIMERIZÁVEL OPTICRYL	Class II
BR	81199279034	ACRÍLICO AUTOPOLIMERIZÁVEL OPTICRYL	Class II
BR	81199279031	DENTES ACRÍLICOS	Class II
CA	99798	NEW STETIC ACRYLIC RESIN TEETH	Class II
CA	99913	DURACRYL FLOW INLAY PATTERN RESIN	Class II
CA	100501	GOOD FIT INSTANT DENTURE SETUPS & INSTANT OVERDENTURES	Class II

New Stetic, SA

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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