Home›USA›ESSENTIAL DENTAL SYSTEMS, INC.

ESSENTIAL DENTAL SYSTEMS, INC.

USA · South Hackensack

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Australia, Israel — 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

20listed device types

Class I 13Class II 6Class III 0unclassified 1

plus 27 registration records and 19 510(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

3active device licences

Class II 3

14 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States27 registration records, 19 510(k), 0 PMA, 3 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: ESSENTIAL DENTAL SYSTEMS, INC. · ESSENTIAL DENTAL SYSTEMS

FDA 510(k) clearances by year

11984

11990

11993

51994

32007

12010

12012

22014

12015

12016

12021

12023

FDA listed device types

showing 8 of 20

Handpiece, Contra- And Right-Angle Attachment, Dental 1Handpiece, Direct Drive, Ac-Powered 1Mirror, Mouth 1Tray, Fluoride, Disposable 1Reamer, Pulp Canal, Endodontic 1Instrument, Filling, Plastic, Dental 1Gutta-Percha 1Handle, Instrument, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223340	EDS Calculus Softener TURBO CR	2023-12-11
US	K202281	EDS Bioceramic Sealer (Bioseal)	2021-02-12
US	K152691	EDS Universal Cement	2016-02-25
CA	66191	PULPOUT BUR	Class II
CA	92817	EDS ULTRASONIC TIPS	Class II
CA	92892	EDS ULTRASONIC PIEZO TIPS INTRO KIT	Class II

ESSENTIAL DENTAL SYSTEMS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies