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Home›Spain›UNION DENTAL S.A.

UNION DENTAL S.A.

Spain · Tielmes
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Russia — 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
6listed device types
Class I 2Class II 3Class III 0unclassified 1
plus 4 registration records and 7 510(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
2 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 States4 registration records, 7 510(k), 0 PMA, 28 excluded
Brazil0 confirmed, 12 excluded
Saudi Arabia0 confirmed, 18 excluded
Manufacturer names merged into this page: UNION DENTAL S.A.
Same-named companies — This database also contains companies with near-identical names: Pacific Union Dental, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Spain
City
Tielmes

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

51986 · K863500
12007 · K070591
12015 · K150432

FDA listed device types

Material, Impression Tray, Resin 1Wax, Dental, Intraoral 1Crown And Bridge, Temporary, Resin 1Denture, Plastic, Teeth 1Resin, Denture, Relining, Repairing, Rebasing 1Mouthguard, Prescription 1

Registration details (sample)

MarketIdentifierNameClass / date
USK150432IDODENTINE DISC, IDODENTINE BLOCK2015-08-14
USK070591REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH2007-05-11
USK863500STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR1986-09-22

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