# Essential Dental Systems, Inc.

- Location (FDA's records): South Hackensack, NJ
- FDA decisions: 18 (1984–2023): 18 510(k) clearances
- Names in FDA's records: Essential Dental Systems, Inc. (17); Essential Dental Systems (1)
- Product codes: EMA (4), KJJ (3), EBF (2), KIF (2), ELC (2), ELW (1), ELR (1), ECR (1), EGS (1), EFT (1)
- 510(k) review time since 2016: median 184 days, against 182 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 18 (1 its own); citations of its devices by later devices: 6 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dentsply Intl.: 4 (https://510kreport.com/company/dentsply-intl)
- Drfp, Ltd.: 2 (https://510kreport.com/company/drfp)
- Dentsply International, Inc.: 1 (https://510kreport.com/company/dentsply-international)
- Coltene/Whaledent, Inc.: 1 (https://510kreport.com/company/coltene-whaledent)
- Mds: 1 (https://510kreport.com/company/mds)
- Nsk Nakanishi, Inc.: 1 (https://510kreport.com/company/nsk-nakanishi)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)
- Union Broach, Div. Moyco Industries, Inc.: 1 (https://510kreport.com/company/union-broach-div-moyco-industries)

## Firms that cite its devices most
- Engineered Endodontics: 1 (https://510kreport.com/company/engineered-endodontics)
- Sterngold/Implamed: 1 (https://510kreport.com/company/sterngold-implamed)
- Dmg USA, Inc.: 1 (https://510kreport.com/company/dmg-usa)
- Pac-Dent International, Inc.: 1 (https://510kreport.com/company/pac-dent-international)
- Inter-Med, Inc.: 1 (https://510kreport.com/company/inter-med)

## Its most-cited devices
- K922249: Flexi-Flow Cement Natural (1994), cited by 2
- K922251: TI-Core-Natural (1994), cited by 1
- K072555: Edta Plus (2007), cited by 1
- K132609: Eds Ultrasonic Tips (2014), cited by 1
- K070401: Endo-CHX (2007), cited by 1

## Recent decisions
- K223340: EDS Calculus Softener TURBO CR (Dec 11, 2023)
- K202281: EDS Bioceramic Sealer (Bioseal) (Feb 12, 2021)
- K152691: EDS Universal Cement (Feb 25, 2016)
- K140846: Eds Combo-Rinse (Jul 25, 2014)
- K132609: Eds Ultrasonic Tips (Jan 22, 2014)
- K111541: Endo-Express (R) Handpiece (Mar 16, 2012)
- K101504: TI-Core Flow (Oct 29, 2010)
- K072555: Edta Plus (Dec 13, 2007)

Source page: https://510kreport.com/company/essential-dental-systems