Home›USA›LuxCreo, Inc.

LuxCreo, Inc.

USA · Chicago

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 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

6listed device types

Class I 3Class II 2Class III 0unclassified 1

plus 6 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States6 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: LUXCREO INC.

FDA 510(k) clearances by year

12022 · K212680

12024 · K230592

22025 · K253365

FDA listed device types

Plate, Base, Shellac 1Positioner, Tooth, Preformed 1Maintainer, Space Preformed, Orthodontic 1Aligner, Sequential 1Resin, Denture, Relining, Repairing, Rebasing 1Mouthguard, Prescription 1

Market	Identifier	Name	Class / date
US	K253365	LuxCreo Flexible Partial Denture Resin	2025-11-25
US	K250343	LuxCreo Clear Aligner System	2025-04-08
US	K230592	LuxCreo Dental Night Guard Resin	2024-01-18

LuxCreo, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies