HomeItalySILFRADENT SRL

SILFRADENT SRL

Italy · Santa Sofia
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, 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
5listed device types
Class I 4Class II 1Class III 0
plus 5 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
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
1active device licences
Class II 1
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
4active ARTG entries
Class I 2IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 1Class 2b 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 States5 registration records, 0 510(k), 0 PMA, 1 excluded
Brazil2 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: SILFRADENT SRL · SILFRADENT S.R.L.

Company information

Country
Italy
City
Santa Sofia

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 listed device types

Unit, Oral Irrigation 1Analyzer, Chemistry, Centrifugal, For Clinical Use 1Warmer, Anesthetic Tube 1Light, Operating, Dental 1Drill, Bone, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81169820005Pontas Surgybone 400Class I
BR81169820007Tubo Irrigação SurgyboneClass II
CA82103SURGYBONE NA (ULTRASONIC DENTAL SCALER)Class II

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