HomeSwitzerlandPOLYDENTIA SA

POLYDENTIA SA

Switzerland · Mezzovico-Vira Ticino
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Israel, Russia — 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
7listed device types
Class I 6Class II 1Class III 0
plus 8 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
23registered devices
Class I 7Class II 16
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
5registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
4valid device licences
Class I 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
7active registrations
Class 2a 7
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 States8 registration records, 1 510(k), 0 PMA
Brazil23 confirmed, 0 excluded
Saudi Arabia5 confirmed, 0 excluded
Manufacturer names merged into this page: POLYDENTIA S.A. · POLYDENTIA SA · Polydentia SA
Same-named companies — This database also contains companies with near-identical names: Polydentia USA. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Switzerland
City
Mezzovico-Vira Ticino

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

11996 · K962374

FDA listed device types

Instruments, Dental Hand 1Dispenser, Liquid Medication 1Accessory, Surgical Apparel 1Point, Abrasive 1Post, Root Canal 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Resin, Denture, Relining, Repairing, Rebasing 1

Registration details (sample)

MarketIdentifierNameClass / date
USK962374FIBER-SPLINT ML MULTILAYER1996-07-22
BR10301959009myQuickmat All-round introkitClass II
BR10301959012myQuickmat Prime KitClass II
BR10301950073Instrumentos de Mão Odontológicos Polydentia em Nitinol (NiTi)Class I
SAME0000011841SFDAA00001Vista-Tech
SAME0000011782SFDAA00006Polydentia

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