510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Essential Dental Systems, Inc.

S Hackensack, NJ, US

ESSENTIAL DENTAL SYSTEMS, INC. appears in FDA device records in S Hackensack, NJ. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Essential Dental Systems, Inc. between 1984 and 2023. The busiest year on record is 1994, with 5. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Essential Dental Systems, Inc., by decision year
YearClearances
19841
19901
19931
19945
20073
20101
20121
20142
20161
20211
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223340EDS Calculus Softener TURBO CRELCSubstantially Equivalent
K202281EDS Bioceramic Sealer (Bioseal)KIFSubstantially Equivalent
K152691EDS Universal CementEMASubstantially Equivalent
K140846EDS COMBO-RINSEKJJSubstantially Equivalent
K132609EDS ULTRASONIC TIPSELCSubstantially Equivalent
K111541ENDO-EXPRESS (R) HANDPIECEEGSSubstantially Equivalent
K101504TI-CORE FLOWEMASubstantially Equivalent
K072555EDTA PLUSKJJSubstantially Equivalent
K070401ENDO-CHXKJJSubstantially Equivalent
K063856EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEMKIFSubstantially Equivalent
K943475ULTRA HYDROPHILIC ALGINAEELWSubstantially Equivalent
K922252TI-CORE NEW & IMPROVEDEBFSubstantially Equivalent
K922251TI-CORE-NATURALEBFSubstantially Equivalent
K922250FLEXI-FLOW CEMENT WITH TITANIUMEMASubstantially Equivalent
K922249FLEXI-FLOW CEMENT NATURALEMASubstantially Equivalent
K914257DENTURE PRODUCT XEFTSubstantially Equivalent
K896693FLEXI-CAST CROWN CORE SYSTEMELRSubstantially Equivalent
K843018FLEXI-POSTECRSubstantially Equivalent

Registered establishments

FDA registered establishments for Essential Dental Systems, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
24336292433629ESSENTIAL DENTAL SYSTEMS, INC.89 LEUNING ST., S Hackensack, NJ 07606 US2026and 10 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain