Manufacturer registered with FDA
Accupac, LLC
Mainland, PA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 57 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Accupac, 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 | Accupac, LLC | 2 device types | — | Below |
| Colombia | INVIMA | Manufacturer | ACCUPAC, LLC | 2 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ACCUPAC, INC.ACCUPAC, LLC | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Accupac, LLCAccupac,Inc. | 2 | 2014–2016 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Accupac, LLC. | 1 | 2016–2016 | 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 Accupac, 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 |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Lister | — | 2021 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | — | 2006 |
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 |
|---|---|---|
| ACCUPAC, LLCFDA reg. 2518467 | MAINLAND, PA, United States | Contract manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2518467). 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.