Manufacturer registered with FDA
The Hygenic Company, LLC
Akron, OH, United States. Lists 1 dental device type with FDA across 2 registered establishments, and holds 13 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 131985–1996
- Markets registered in
- 1158 registrations outside the US
- Establishments
- 2Malaysia, United States
510(k) clearances per year, 1980–2026
Registered in 11 markets
Where regulators' registries name The Hygenic Company, LLC 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 | The Hygenic Company, LLC | 13 clearances | 1985–1996 | Below |
| European Union | EUDAMED | Manufacturer | The Hygenic Company, LLC | 14 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | The Hygenic Corporation | 13 | 2012–2016 | Pure Global AI |
| Australia | TGA | Manufacturer | The Hygenic Company LLC | 10 | 2017–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | The Hygenic Company LLC | 10 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | The Hygenic Company, LLC | 5 | 2023–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | THE HYGENIC CORPORATION | 2 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | THE HYGENIC COMPANY, LLC | 1 | 2001–2001 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | THE HYGENIC COMPANY, LLC. | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | The Hygenic Corporation | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Hygenic Corporation | 1 | 2013–2013 | 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 The Hygenic Company, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Elasti-DamFiesta Dental DamFlexi Dam Non-LatexFramed Flexi Dam Non-LatexHYGENIC DENTAL DAMNON-LATEX DENTAL DAMRubber Dam | 1977 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names The Hygenic Company, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 26 Jan 1996 | K954990 | DENTAL DAM | EIE Rubber Dam |
| 27 May 1993 | K930764 | ENDO-ICE-PULP TESTER-THERMAL | EAT Pulp Tester |
| 25 Jul 1991 | K905418 | GATES GLIDDEN DRILLS | DZA Intraoral Dental Drill |
| 5 Mar 1991 | K905640 | SOLID CORE GUTTA PERCHA CARRIER | EKS Endodontic Pulp Canal File |
| 15 May 1990 | K900301 | NOVUS BONDING AGENT | EBI Rebasing Repairing Relining Denture Resin |
| 16 Apr 1990 | K900844 | WEDJETS | EIE Rubber Dam |
| 10 Jan 1990 | K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) | KIF Root Canal Filling Resin |
| 23 Aug 1988 | K881826 | ENDO-ICE | EAT Pulp Tester |
| 27 Oct 1987 | K873644 | PULP PEN | EAT Pulp Tester |
| 10 Mar 1986 | K854529 | INLAY WAX REGULAR | EGD Intraoral Dental Wax |
| 4 Mar 1986 | K854530 | PREMIUM FLEXI-TOUGH | EGD Intraoral Dental Wax |
| 4 Mar 1986 | K854527 | STICKY WAX | EGD Intraoral Dental Wax |
| 16 Apr 1985 | K850863 | ULTRAFIL-LT (GUTTA PERCHA) | EKM Gutta-Percha |
Some of these clearances are listed with FDA today by another company: Coltene/Whaledent AG (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| THE HYGENIC COMPANY, LLCFDA reg. 1519375 | Akron, OH, United States | Contract manufacturer, Manufacturer |
| The Hygenic CorporationFDA reg. 9681338 | Batu Gajah Perak, Malaysia | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1519375). 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.