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Bicon, Inc.

USA · Boston

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 8 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

18listed device types

Class I 11Class II 6Class III 0unclassified 1

plus 27 registration records and 18 510(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

4active device licences

Class II 3Class III 1

17 including historic records

TWTaiwanTFDA

9valid device licences

Class I 1Class II 3Class III 5

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class III 1IIa 1IIb 2

HKHong KongMDACS

5valid listings

Class II 2Class III 2Class IV 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 3Class 3 1

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 States27 registration records, 18 510(k), 0 PMA

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: BICON, LLC

FDA 510(k) clearances by year

31997

11999

12000

12002

12003

22004

32005

12006

12008

12009

12010

12014

12015

FDA listed device types

showing 8 of 18

Cleanser, Root Canal 1Resin, Denture, Relining, Repairing, Rebasing 1Abutment, Implant, Dental, Endosseous 1Material, Tooth Shade, Resin 1Bone Grafting Material, Synthetic 1Crown And Bridge, Temporary, Resin 1Implant, Endosseous, Root-Form 1Bur, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K143524	Fiber Disks and Blocks (TRINIA)	2015-06-02
US	K133608	TRINIA	2014-03-14
US	K101849	BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT	2010-10-01
CA	35038	DENTAL BONE SCREW	Class III
CA	67091	ELECTRIC DRILL UNIT (110V)	Class II
CA	67092	CONTRO-ANGLE HANDPIECE	Class II

Bicon, 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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