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Sprintray, Inc.

USA · Los Angeles

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 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

11listed device types

Class I 5Class II 5Class III 0unclassified 1

plus 30 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

15registered devices

Class I 9Class II 6

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

9 including historic records

TWTaiwanTFDA

4valid device licences

Class I 2Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IIa 2

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 States30 registration records, 9 510(k), 0 PMA

Brazil15 confirmed, 0 excluded

Manufacturer names merged into this page: SPRINTRAY INC.

FDA 510(k) clearances by year

12021

32022 · K222623

12023 · K230445

22024 · K242559

12025 · K250617

12026 · K260661

FDA listed device types

showing 8 of 11

Additively Manufactured, Preformed, Resin Denture Tooth 1Resin, Denture, Relining, Repairing, Rebasing 1Material, Tooth Shade, Resin 1Crown And Bridge, Temporary, Resin 1Denture, Plastic, Teeth 1Indirect Bonding Tray 1Positioner, Tooth, Preformed 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260661	Midas Restore	2026-04-15
US	K250617	Apex Flex	2025-04-29
US	K242559	Digital Temp	2024-11-26
BR	80117581219	Try-In 2	Class I
BR	80117589136	APEX Base	Class II
BR	80117589137	APEX Teeth	Class II

Sprintray, Inc.

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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