HomeSwitzerlandCOLTENE/WHALEDENT GMBH & CO. KG

COLTENE/WHALEDENT GMBH & CO. KG

Switzerland · Altstaetten
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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
49listed device types
Class I 34Class II 12Class III 0unclassified 3
plus 95 registration records and 41 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
24registered devices
Class I 15Class II 9
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
24registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
19active device licences
Class II 9Class III 10
72 including historic records
TWTaiwanTFDA
52valid device licences
Class I 32Class II 19Class III 1
SGSingaporeHSA SMDR
19device registrations
CLASS B 18CLASS D 1
KRSouth KoreaMFDS GMP
4GMP quality-system certificates
Import 4
AUAustraliaTGA ARTG
56active ARTG entries
Class I 30Class III 1IIa 23IIb 1Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
13registrations
RURussiaRoszdravnadzor
24active registrations
Class 1 7Class 2a 16Class 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 States95 registration records, 41 510(k), 0 PMA, 1 excluded
Brazil24 confirmed, 0 excluded
Saudi Arabia24 confirmed, 0 excluded
Canada19 confirmed, 0 excluded
Manufacturer names merged into this page: COLTENE/WHALEDENT AG · COLTENE/WHALEDENT INC. · COLTENE/WHALEDENT GMBH & CO. KG · COLTENE/WHALEDENT, INC. · COLTENE/WHALEDENT GMBH + CO. KG · COLTENE WHALEDENT AG

Company information

Country
Switzerland
City
Altstaetten

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11992
11994
31995
21998
41999
32000
12001
22003
32004
52005
12006
22007
12009
12011
22013
22015
22016
12018
22019
12022

FDA listed device types

showing 8 of 49
Activator, Ultraviolet, For Polymerization 1Cement, Dental 1Catheter And Tip, Suction 1Tester, Pulp 1Sterilizer, Dry Heat 1Scaler, Ultrasonic 1Material, Tooth Shade, Resin 1Material, Impression 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220097PRESIDENT The Original2022-01-13
USK191385BRILLIANT COMPONEER2019-10-29
USK190597BRILLIANT EverGlow Flow2019-06-21
BR81118639013HYGENIC Guttapercha PointsClass II
BR81118630058HANEL Occlusion FoilClass I
BR81118630036Steal Separating StripsClass I
SAME0000012191SFDAA00038Roeko
SAME0000011780SFDAA00013HYGENIC CLAMP
CA61555ADHESIVE, BRACKET AND CONDITIONER, RESINClass II
CA69087TEMPOSILClass III
CA104715BRILLIANT COMPONEERClass III

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