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SMART DENTURE CONVERSIONS, LLC

USA · Apex

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 3 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

7listed device types

Class I 4Class II 3Class III 0

plus 12 registration records and 2 510(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

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 8IIa 1IIb 2

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 States12 registration records, 2 510(k), 0 PMA, 3 excluded

Manufacturer names merged into this page: SMART DENTURE CONVERSIONS, LLC

FDA 510(k) clearances by year

12025 · K242064

12026 · K254145

FDA listed device types

Implant, Endosseous, Root-Form 1Material, Tooth Shade, Resin 1Abutment, Implant, Dental, Endosseous 1Accessories, Implant, Dental, Endosseous 1Tray, Impression, Preformed 1Dam, Rubber 1Anchor, Preformed 1

Market	Identifier	Name	Class / date
US	K254145	Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)	2026-06-11
US	K242064	Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut)	2025-01-17

SMART DENTURE CONVERSIONS, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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