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RHEIN 83 SRL

Italy · Bologna Emilia-Romagna

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

8listed device types

Class I 6Class II 2Class III 0

plus 10 registration records and 4 510(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

0active device licences

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States10 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: RHEIN 83 SRL · RHEIN 83 S.R.L.

FDA 510(k) clearances by year

12004 · K033630

12015 · K142211

12016 · K160382

12018 · K171409

FDA listed device types

Attachment, Precision, All 1Accessories, Implant, Dental, Endosseous 1Anchor, Preformed 1Drill, Dental, Intraoral 1Post, Root Canal 1Gauge, Depth, Instrument, Dental 1Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1

Market	Identifier	Name	Class / date
US	K171409	OT EQUATOR	2018-04-09
US	K160382	OT EQUATOR	2016-08-11
US	K142211	OT EQUATOR	2015-11-25

RHEIN 83 SRL

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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