Data / Medical devices / Israel / Dsi Dental Solutions Ltd

Dsi Dental Solutions Ltd: FDA-registered device maker in Ashdod Southern, Israel, 7 510(k) clearances

Name: Dsi Dental Solutions Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dsi Dental Solutions Ltd is registered with the FDA (registration 3016447764) in Ashdod Southern, Israel. It lists 26 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 23, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016447764
Address: 59 ha Avoda St Light Industrial Zone, Ashdod Southern, Israel, 7706300
Owner or operator: DSI Dental Solutions Ltd (10062297)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: June 9, 2020
Registered through: 2026
Brand names listed: ApexPaste, ApexPaste Bio, ApexPaste Hard, ApexPaste I, ApexSil RC, ApexSil Silver, CalPaste LC, DSI ApexCream EDTA RC Preparation Cream and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)	KOQ	1	Repackager or relabeler	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Resin	KXR	1	Repackager or relabeler	accessdata.fda.gov
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium	KOT	1	Repackager or relabeler	accessdata.fda.gov
Cement, Dental	EMA	2	Repackager or relabeler	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Repackager or relabeler	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Repackager or relabeler	accessdata.fda.gov
Cushion, Denture, Over The Counter	EHS	2	Repackager or relabeler	accessdata.fda.gov
Dam, Rubber	EIE	1	Repackager or relabeler	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Repackager or relabeler	accessdata.fda.gov
Gauge, Depth, Instrument, Dental	EIL	1	Repackager or relabeler	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Repackager or relabeler	accessdata.fda.gov
Material, Impression	ELW	2	Repackager or relabeler	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Repackager or relabeler	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Non-Irrigation Endosseous Dental Implant Drill Bits	QRQ	1	Specification developer	accessdata.fda.gov
Paper, Articulation	EFH	1	Repackager or relabeler	accessdata.fda.gov
Plaque Disclosing Agent	QJC	1	Repackager or relabeler	accessdata.fda.gov
Preparer, Root Canal Endodontic	EKQ	1	Repackager or relabeler	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Repackager or relabeler	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Repackager or relabeler	accessdata.fda.gov
Tray, Fluoride, Disposable	KMT	1	Repackager or relabeler	accessdata.fda.gov
Zinc Oxide Eugenol	EMB	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 23, 2025	K250778	Sil-Flow	EBF	Substantially Equivalent	Dsi Dental Solutions, Ltd.	accessdata.fda.gov
November 7, 2022	K222741	DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)	ELW	Substantially Equivalent	Hdi, Inc.	accessdata.fda.gov
September 23, 2022	K213339	DENU Composite Resin, DENU Flow Resin	EBF	Substantially Equivalent	Hdi, Inc.	accessdata.fda.gov
May 23, 2022	K212563	CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid	KIF	Substantially Equivalent	Prevest Denpro Limited	accessdata.fda.gov
May 13, 2022	K212475	Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)	EJK	Substantially Equivalent	Prevest Denpro Limited	accessdata.fda.gov
May 13, 2021	K200555	Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)	EMA	Substantially Equivalent	Prevest Denpro Limited	accessdata.fda.gov
April 1, 2020	K200188	DSI Dental Implant System	DZE	Substantially Equivalent	Dsi Dental Solutions, Ltd.	accessdata.fda.gov

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Updated May 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.