Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2433629

FEI Number

2433629

Entity Name

ESSENTIAL DENTAL SYSTEMS, INC.

City/State/Country

S Hackensack, NJ, US

Establishment Address

89 LEUNING ST., S Hackensack, NJ 07606, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ESSENTIAL DENTAL SYSTEMS, INC. (Owner Number: 2433629)

Owner / Operator Contact Address

89 LEUNING ST., --, South Hackensack, NJ 07606, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K992727

PMA Number

N/A

All Registered Proprietary Names

Bio-LCB EDS Depth Gauge Countersink Drill Primary Reamer, Secondary Drill, Gates Glidden Drill, Peeso Reamer, Pleezer Reamer Steri Tracker EDS Self Etch Bonding Agent Flexi-Flow Auto E Endo CSV LED Light Flexi-Post, Flexi-Overdenture, Flexi-Flange, EDS' AccessPost, EDS AccessPost Overdenture, EZ Fit Translucent ENDO-CHX Ti-Core Flow Plus, Ti-Core Auto E EDTA Plus Ti-Core Endo-Express C-MOR CEMPOWER SafeSiders Gutta Percha Points Safesider HF Gutta Percha Points Turbo-CR EZ-Fill Bi-Directional Spiral EZ-Fill Cement EZ-Fill Root Canal Cement

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2022-10-07
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2017-10-06
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2025-02-18
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2006-06-30
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2009-12-02
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2017-01-16
EMA	Cement, Dental	Dental	Class 2	872.3275	1992-07-16
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2019-10-15
ELR	Post, Root Canal	Dental	Class 1	872.3810	1990-06-07
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2007-08-01
EMA	Cement, Dental	Dental	Class 2	872.3275	2012-10-10
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2008-04-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2006-06-30
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2007-11-01
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2011-09-21
EMA	Cement, Dental	Dental	Class 2	872.3275	2023-11-13
EKM	Gutta-Percha	Dental	Class 1	872.3850	2007-04-05
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-02-18
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2007-11-01

Official Correspondent

JOEL BURSTEIN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ESSENTIAL DENTAL SYSTEMS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K941532	Bio-Probe, Inc.	BIOCALEX 6/9	1994-08-02
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0011-2020	Inter-Med Llc	U	Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2433629. Last updated year: 2026. Please use registration number 2433629 when referencing this establishment in official correspondence.