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Home›USA›PARAGON IMPLANT COMPANY, LLC

PARAGON IMPLANT COMPANY, LLC

USA · Las Vegas
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
5listed device types
Class I 2Class II 3Class III 0
plus 11 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
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 States11 registration records, 4 510(k), 0 PMA, 22 excluded
Brazil0 confirmed, 2 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: PARAGON IMPLANT MFG., LLC · PARAGON IMPLANT COMPANY, LLC
Same-named companies — This database also contains companies with near-identical names: PARAGON IMPLANT MFG., LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Las Vegas

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

42025 · K252145

FDA listed device types

Implant, Endosseous, Root-Form 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Abutment, Implant, Dental, Endosseous 1Accessories, Implant, Dental, Endosseous 1Non-Irrigation Endosseous Dental Implant Drill Bits 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252145GEN5™ and GEN5+™ 3.3mmD Dental Implants2025-12-23
USK250476NizPlant Dental Implant System2025-12-23
USK251756Sterilization Trays2025-11-14

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