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BISCO, INC.

USA · Schaumburg

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

15listed device types

Class I 3Class II 12Class III 0

plus 72 registration records and 88 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

20registered devices

Class I 1Class II 19

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

5active device licences

Class II 1Class III 4

27 including historic records

TWTaiwanTFDA

19valid device licences

Class II 19

SGSingaporeHSA SMDR

9device registrations

CLASS B 9

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 1Manufacturing 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 2IIa 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

12active registrations

Class 1 2Class 2a 10

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 States72 registration records, 88 510(k), 0 PMA

Brazil20 confirmed, 0 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: BISCO, INC. · BISCO INC · BISCO INC.

FDA 510(k) clearances by year

52003

42004

42005

32006

12007

22008

12009

42010

22011

12012

12013

22014

12015

22016

32017

12018

12019

12020

12024

12025

FDA listed device types

showing 8 of 15

Applicator, Resin 1Syringe, Restorative And Impression Material 1Wax, Dental, Intraoral 1Sealant, Pit And Fissure, And Conditioner 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Adhesive, Bracket And Tooth Conditioner, Resin 1Liner, Cavity, Calcium Hydroxide 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250156	Choice 2 DC	2025-07-11
US	K242816	Quantium	2024-12-17
US	K192007	TheraBase, TheraBase Ca	2020-03-17
BR	10336460070	SISTEMA DE ADESIVO ODONTOLOGICO	Class II
BR	10336460068	ONE STEP PLUS	Class II
BR	10336460071	BISCOVER LV	Class II
CA	101344	REVEAL HD BULK	Class III
CA	103486	PRO-V C&B	Class II
CA	30235	INTRAORAL AQUEOUS REWETTING AGENT	Class III

BISCO, 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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