Not currently registered with FDA under this name
Parker Laboratories, Inc.
Farmingdale, NY, United States. Named as applicant on 12 dental 510(k) clearances between 1977 and 1986. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 121977–1986
- Markets registered in
- 14106 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1976–2026
Registered in 14 markets
Where regulators' registries name Parker Laboratories, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Parker Laboratories, Inc. | 12 clearances | 1977–1986 | Below |
| South Korea | MFDS | Manufacturer | Parker Laboratories, Inc.Parker Laboratories Inc · PARKER LABORATORIES, INC. · +2 | 37 | 2015–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Parker Laboratories Inc | 14 | 2007–2020 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Parker Laboratories, Inc. | 14 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | PARKER LABORATORIES, INCPARKER LABORATORIES INC. | 9 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Parker Laboratories, Inc. | 9 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | PARKER LABORATORIES INC. | 5 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Parker Laboratories Inc.Parker Laboratories, Inc. · PARKER LABORATORIES, INC | 5 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | PARKER LABORATORIES INC. | 4 | 1999–2002 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PARKER LABORATORIES, INCPARKER LABORATORIES, INC. | 4 | 2008–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PARKER LABORATORIES, INC.Parker Laboratories, Inc | 2 | 2020–2020 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Parker Laboratories, Inc. | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Parker Laboratories, Inc. | 1 | 2023–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Parker Laboratories, Inc. | 1 | 2006–2006 | 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
510(k) clearances
Clearances on which FDA names Parker Laboratories, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Apr 1986 | K861239 | ACRYLIC SOLDER | EBI Rebasing Repairing Relining Denture Resin |
| 4 Mar 1986 | K855167 | DYNA SYSTEM | EGG All Precision Attachment |
| 17 Apr 1984 | K840548 | RESIL | EBI Rebasing Repairing Relining Denture Resin |
| 22 Oct 1982 | K822896 | CAVIDRY | EJH Base Metal Alloy |
| 23 Jan 1980 | K800060 | PROVIT | EMA Dental Cement |
| 17 Jan 1980 | K790555 | HEMO-WEDGE | DZN Dental Hand Instruments |
| 6 Dec 1979 | K792391 | COTTON ROLL COMPRESSION CAPS | EFN Roll Cotton |
| 16 Aug 1977 | K771527 | ACCU. CROWN COLD CURE | EBG Resin Temporary Crown and Bridge |
| 20 Jun 1977 | K771011 | ARTICULATING PAPER | EFH Articulation Paper |
| 26 Apr 1977 | K770685 | LIGHT, EXAMINING, DENTAL, ULTRA VIOLET | EAQ Ultraviolet Detector |
| 26 Apr 1977 | K770684 | CROWN, ACRYLIC, CORAL BRAND, PREFORMED | ELZ Preformed Crown |
| 25 Jan 1977 | K770067 | CYANOBOND | EMA Dental Cement |
Some of these clearances are listed with FDA today by another company: Parkell, Inc (2), Polydentia S.A. (1).
Sources
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 of the most recent filing, which can be a US agent.