Manufacturer registered with FDA
Dukal Corporation
Ronkonkoma, NY, United States. Lists 17 dental device types with FDA across 1 registered establishment.
- Device types listed
- 17
- Brands and models
- 17
- 510(k) clearances
- 0as applicant
- Markets registered in
- 593 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Dukal Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Dukal Corporation | 17 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Dukal Corporation | 48 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | DUKAL LLCDUKAL CORPORATION | 41 | 1999–2020 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DUKAL CORPORATION | 3 | 2015–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Dukal LLC | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Dukal Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | Saliva Ejectors(Multiple Private Label Brands) | 2021 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | Unipack Air/Water Syringe Tips, including private label. | 2024 |
| Roll CottonEFN · Class 1 | — | Maker | Dukal Cotton Roll | 2004 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | DawnMist Denture Cleanser Tablets | 2012 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | DawnMist Toothbrush | 2012 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | Private label-Self-Adhesive Bite-Wing Tabs | 2025 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | Unipack Prophy Angles | 2021 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Unipack Impression Trays Perforated | 2021 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Dukal Evacuation Products & Accessories, including Private Label. | 2020 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Lister | Unipack Air/Water Syringe Tips | 2021 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Unipack Pre-Bent Dispensing Tips | 2021 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | Unipack Micro Applicators | 2021 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | Dukal Patient Bibs | 2019 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | Unipack Fluoride Trays | 2021 |
| Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Denture AdhesiveKOO · Class 1 | Denture cleansers & adhesives | Lister | DawnMist Denture Adhesive | 2020 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Dukal Air Water Syringe Sleeves | 2019 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Dukal Headrest Covers | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DUKAL LLCFDA reg. 2435946 | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9005925). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.