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Pentron Clinical

USA · Orange

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, 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

17510(k) clearances

Class I 0Class II 0Class III 0

plus 0 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

23active device licences

Class II 4Class III 19

28 including historic records

TWTaiwanTFDA

13valid device licences

Class I 3Class II 10

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2IIa 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

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 States0 registration records, 17 510(k), 0 PMA, 4 excluded

Canada23 confirmed, 1 excluded

Manufacturer names merged into this page: PENTRON CLINICAL TECHNOLOGIES, LLC · KERR CORPORATION, ALSO TRADING AS PENTRON CLINICAL

Same-named companies — This database also contains companies with near-identical names: KERR CORPORATION, ALSO TRADING AS PENTRON CLINICAL, PENTRON CLINICAL TECHNOLOGIES, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130920	CORRECT PLUS 1	2013-07-02
US	K120013	TEMPSPAN CLEAR MATRIX	2012-05-22
US	K111431	B1P ADHESIVE	2011-08-01
CA	65519	BOND-IT SYSTEM	Class III
CA	65530	EPIPHANY ENDODONTIC OBTURATION SYSTEM	Class III
CA	65607	SIMILE COMPOSITE	Class III

Pentron Clinical

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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