FDA Registration
Active
🇮🇱 Israel
DSI DENTAL SOLUTIONS LTD
Reg #: 3016447764
·
FEI: 3016447764
·
Expires 2026
Products
26
Proprietary Names
38
Establishment Types
3
Classifications
26
Registration Details
- Registration Name
- DSI DENTAL SOLUTIONS LTD
- Registration Number
- 3016447764
- FEI Number
- 3016447764
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 59 ha Avoda St, Light Industrial Zone
- City
- Ashdod Southern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K213339
Owner / Operator
- Firm Name
- DSI Dental Solutions Ltd
- Operator Number
- 10062297
- Address
- 59 ha Avoda St, Light Industrial Zone
- City
- Ashdod
- State
- Southern
- Postal Code
- 7706300
- Country
- IL
US Agent
- Business Name
- Blackwell Device Consulting
- Contact Name
- Angela Blackwell
- Address
- 16409 Se Division St Ste 216
- City
- Portland
- State
- OR
- ZIP
- 97236
- Country
- US
- [email protected]
- Phone
- 704 4509934
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2023-11-29 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2023-11-29 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2023-11-29 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2023-11-29 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2023-11-29 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 2023-11-29 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2021-04-27 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2022-12-19 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2023-11-29 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2022-12-19 |
| Material, Impression | ELW | Class 2 | Dental | No | 2023-11-29 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2022-12-19 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2023-11-29 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2022-12-19 |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | Class 1 | Dental | No | 2026-02-04 |
| Cushion, Denture, Over The Counter | EHS | Class 2 | Dental | No | 2025-12-01 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2023-11-29 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2020-06-09 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2020-06-09 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2023-11-29 |
| Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | KOT | Class 1 | Dental | No | 2025-12-01 |
| Plaque Disclosing Agent | QJC | Class 1 | Dental | No | 2025-12-01 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2022-12-19 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2023-11-29 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2025-12-01 |
| Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) | KOQ | Class 1 | Dental | No | 2025-12-01 |
Proprietary Names
Unilite Blockout Material
Jig Sculpting Light Cure Pattern Modeling Resin
DSI Implant Jig Paste Light Cure Pattern Modeling Resin
DSI ApexCream EDTA RC Preparation Cream
DSI Veneer Stick Adhesive Tip Holders
Unilite Universal Composite
Unilite Flow Kit
Unilite Flow
DSI OccuFoil
DSI Dental Implant tools and accessories
ApexSil Silver
ReMTA One
ApexSil RC
ZOER RC Automix
Plastic Probe
ApexPaste
ApexPaste Bio
CalPaste LC
ApexPaste Hard
ApexPaste I
UltraSil Putty
UltraSil Light Body Wash
UltraSil Heavy Body Wash
Zoer Quick
ZOER Reinforced
Sil-Flow
DSI T-Clean Temporary Cement Cleaner
Glass-FX Micro
Glass-FX Bio
Glass-FX Clear
Glass-FX Conditioner
DSI Dental Implant Drills
DSI Impression Tray Cleaner Powder
DSI Dental Implant System
Unilite Dam Liquid LC Material
Pumice Paste
DSI Prophylaxis Paste
Fluoride Gel Tray
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility