Home›Italy›DENTAL MANUFACTURING SPA

DENTAL MANUFACTURING SPA

Italy · Badia Polesine Rovigo

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

22listed device types

Class I 12Class II 9Class III 0unclassified 1

plus 26 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

2 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 States26 registration records, 17 510(k), 0 PMA, 891 excluded

Brazil8 confirmed, 131 excluded

Saudi Arabia1 confirmed, 101 excluded

Canada0 confirmed, 167 excluded

Manufacturer names merged into this page: DENTAL MANUFACTURING SPA · PRIME DENTAL MANUFACTURING, INC. · DENTAL MANUFACTURING S.P.A. · PRIME DENTAL MANUFACTURING, INC · DENTAL MANUFACTURING S. P. A. · Prime Dental Manufacturing Inc.

FDA 510(k) clearances by year

11986

31987

21988

22000

32001

42002

12012

12026

FDA listed device types

showing 8 of 22

Sealant, Pit And Fissure, And Conditioner 1Additively Manufactured, Preformed, Resin Denture Tooth 1Resin, Denture, Relining, Repairing, Rebasing 1Cement, Dental 1Adhesive, Bracket And Tooth Conditioner, Resin 1External Cleaning Solution 1Material, Tooth Shade, Resin 1Crown And Bridge, Temporary, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261456	Ruthinium Disc	2026-08-05
US	K112574	PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT	2012-01-23
US	K022675	PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL	2002-11-07
BR	80801630040	Acry Smart	Class II
BR	80801630041	Acry Lux	Class II
BR	80801630014	Nobile-2	Class II
SA	ME0000005597SFDAA00001	Prime Gel	—

DENTAL MANUFACTURING SPA

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies