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JENSEN INDUSTRIES, INCORPORATED

USA · North Haven

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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 1Class II 5Class III 0

plus 10 registration records and 17 510(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

7active device licences

Class III 7

10 including historic records

TWTaiwanTFDA

0valid device licences

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 States10 registration records, 17 510(k), 0 PMA, 2 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: JENSEN INDUSTRIES, INC. · JENSEN INDUSTRIES, INCORPORATED

FDA 510(k) clearances by year

11998

32000

32001

12002

12003

12004

22005

12007

22011

12014

12019

FDA listed device types

Teeth, Porcelain 1Alloy, Gold-Based Noble Metal 1Powder, Porcelain 1Crown And Bridge, Temporary, Resin 1Alloy, Other Noble Metal 1Articulators 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K183408	Jensen Shade Effect Liquids	2019-03-20
US	K142043	INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA	2014-12-18
US	K112806	JENSEN ZIRCONIA	2011-12-01
CA	79493	PULSE SYSTEM (PRESS TO METAL)	Class III
CA	79494	AUTHENTIC SYSTEM	Class III
CA	79495	AUTHENTIC - PULSE SYSTEM	Class III

JENSEN INDUSTRIES, INCORPORATED

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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