FDA.reportPublic FDA data

ESSENTIAL DENTAL SYSTEMS, INC.

Matched from indexed company URL: Essential Dental Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24336292433629ESSENTIAL DENTAL SYSTEMS, INC.1N2026-01-0189 LEUNING ST. S Hackensack NJ US 07606

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00766054000341EDS Self Etch Bonding Agent - Self Etch Bonding Agent+1(201)487-9090udi@edsdental.com
00766054001201Endo-Express - Endo-Express E Type 4-Hole Air Motor+1(201)487-9090udi@edsdental.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
375281586857157K992727THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEMKIF2000-01-18
375281830383417K984503ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000KLE1999-02-26
375281628947872K962540E-TYPE CONTRA ANGLE NAC-EEGS1996-09-12
375281912527495K922252TI-CORE NEW & IMPROVEDEBF1994-01-26
375281726496269K922251TI-CORE-NATURALEBF1994-01-26
375281792763818K922250FLEXI-FLOW CEMENT WITH TITANIUMEMA1994-01-26
375281790275284K922249FLEXI-FLOW CEMENT NATURALEMA1994-01-26
375281222354836K223340EDS Calculus Softener TURBO CRELC2023-12-11
375281102347071K214076EsCemEMA2022-12-19
375281889127976K202281EDS Bioceramic Sealer (Bioseal)KIF2021-02-12
375281326640704K152691EDS Universal CementEMA2016-02-25
375281895777598K150020Irritrol, EDS Combo-RinseKJJ2015-02-25
375281255216670K134022BASE ITEJK2014-06-11
375281863686372K132609EDS ULTRASONIC TIPSELC2014-01-22
375281846975538K101504TI-CORE FLOWEMA2010-10-29
375281727866321K092833ENDOMAX CORDLESS ENDODONTIC HANDPIECEEKX2010-01-07
375281857446355K072555EDTA PLUSKJJ2007-12-13
375281829510717K070401ENDO-CHXKJJ2007-07-11
375281217786727K063856EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEMKIF2007-02-06
375281244803448
375281290579911
375281380608915
375281434921978
375281741661479
375281750983146
375281785626592
375281843883857
375281850673921
375281901933302
375281965047887

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EMA52022-12-19
KIF32021-02-12
KJJ32015-02-25
ELC22023-12-11
EBF21994-01-26
EJK12014-06-11
EKX12010-01-07
KLE11999-02-26
EGS11996-09-12

PMN#

EDTA PLUS

2007-12-13

ESSENTIAL DENTAL SYSTEMS, INC.

ENDO-CHX

2007-07-11

ESSENTIAL DENTAL SYSTEMS, INC.

FLEXI-POST

1984-09-27

ESSENTIAL DENTAL SYSTEMS, INC.

GUDID#

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