Manufacturer registered with FDA
Bioseal
Placentia, CA, United States. Lists 12 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 12
- Brands and models
- 11
- 510(k) clearances
- 11988–1988
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name Bioseal 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 | Bioseal | 1 clearances | 1988–1988 | Below |
| Colombia | INVIMA | Manufacturer | BIOSEAL | 2 | — | 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 Bioseal 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 | — | Maker | Saliva Ejector | 2019 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Implanova | 2018 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | — | 2026 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | sterile bands | 1988 |
| Roll CottonEFN · Class 1 | — | Maker | Dental Roll | 2016 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrush, Sterile | 2010 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Sheet Silastic | 2016 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Bioseal Cheek Retractor | 2023 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Bur | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental Floss | 2022 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Toothpick | 2018 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Implanova | 2018 |
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 |
|---|---|---|
| BIOSEALFDA reg. 2027062 | PLACENTIA, CA, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2027062). 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.