Manufacturer registered with FDA
TePe Munhygienprodukter AB
Malmo, Sweden. Lists 4 dental device types with FDA across 2 registered establishments.
- Device types listed
- 4
- Brands and models
- 24
- 510(k) clearances
- 0as applicant
- Markets registered in
- 310 registrations outside the US
- Establishments
- 2Sweden, United States
Registered in 3 markets
Where regulators' registries name TePe Munhygienprodukter AB 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 | TePe Munhygienprodukter AB | 4 device types | — | Below |
| European Union | EUDAMED | Manufacturer | TePe Munhygienprodukter AB | 9 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TEPE MUNHYGIENPRODUKTER AB | 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 TePe Munhygienprodukter AB currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | TePe AngleTePe ChoiceTePe ColourTePe Compact TuftTePe Denture CareTePe EasyFitTePe Gentle CareTePe GoodTePe Implant Orthodontic BrushTePe Interdental Brush 8 moreTePe InterspaceTePe KidsTePe MiniTePe NovaTePe SelectTePe Special CareTePe SupremeTePe Universal Care | 2003 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental FlossTePe Bridge & Implant FlossTePe Mini FlosserTePe Mini Flosser Good | 2003 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | TePe EasyPick | 2014 |
| Tongue ScraperLCN · Class 1 | — | Maker | TePe Tongue Cleaner | 2004 |
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 |
|---|---|---|
| TEPE MUNHYGIENPRODUKTER ABFDA reg. 3003761382 | MALMO Skane, Sweden | Manufacturer, Repacker / relabeler |
| TEPE ORAL HEALTH CARE, INC.FDA reg. 2087561 | Anaheim, CA, United States | Repacker / relabeler |
Other names on FDA records
Tepe Oral Health Care, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9058216). 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.