Manufacturer registered with FDA
Havpak, Inc.
Malvern, PA, United States. Lists 2 dental device types with FDA across 2 registered establishments.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 2United States
Registered in 2 markets
Where regulators' registries name Havpak, 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 | Manufacturer | Havpak, Inc. | 2 device types | — | Below |
| Colombia | INVIMA | Manufacturer | HAVPAK, INC.HAVPAK, INC | 3 | — | 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 Havpak, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | GLIDE DENTAL FLOSS PRODUCTGLIDE FLOSSProcter & Gamble | 1998 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | — | 2020 |
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 |
|---|---|---|
| Havpak, Inc.FDA reg. 3014387063 | Malvern, PA, United States | Contract manufacturer |
| HAVPAK, INC.FDA reg. 2529851 | Malvern, PA, United States | Contract manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9033889). 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.