HomeTürkiyeImicryl Dis Malzemeleri San. VE Tic. A.S.

Imicryl Dis Malzemeleri San. VE Tic. A.S.

Türkiye · Konya
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 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
41listed device types
Class I 26Class II 10Class III 0unclassified 5
plus 41 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
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 States41 registration records, 6 510(k), 0 PMA
Saudi Arabia4 confirmed, 0 excluded
Manufacturer names merged into this page: IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. · IMICRYL DIS MALZEMELERI SAN VE TIC A.S
Same-named companies — This database also contains companies with near-identical names: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Türkiye
City
Konya

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

12019 · K192178
22021 · K210473
32022 · K213609

FDA listed device types

showing 8 of 41
Preparer, Root Canal Endodontic 1Material, Impression Tray, Resin 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter 1Zinc Oxide Eugenol 1Pin, Retentive And Splinting, And Accessory Instruments 1Absorber, Saliva, Paper 1Plate, Base, Shellac 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213609NOVA RESIN dual cure, self adhesive resin cement2022-08-09
USK220077IMICRYL Composite, Composite Flow Materials2022-08-09
USK213890IMICRYL Impression Materials2022-02-11
SAME0000000102SFDAA00003IMIBASE
SAME0000000102SFDAA00004IMIWAX

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