HomeKorea, RepublicBioMTA

BioMTA

Korea, Republic · Daejeon
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia — 5 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 5Class II 1Class III 0
plus 7 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class 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
0active device licences
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1IIa 1
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 States7 registration records, 1 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: BioMTA

Company information

Country
Korea, Republic
City
Daejeon

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

12014 · K132825

FDA listed device types

Resin, Root Canal Filling 1Spreader, Pulp Canal Filling Material, Endodontic 1Plugger, Root Canal, Endodontic 1Instrument, Filling, Plastic, Dental 1File, Pulp Canal, Endodontic 1Scaler, Periodontic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK132825RETROMTA-ORTHOMTA II2014-04-10
BR80442209001BIOMTAClass II

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