Manufacturer registered with FDA
Biotech Dental Smilers, SAS
Salon de Provence, France. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 6
- 510(k) clearances
- 12021–2021
- Markets registered in
- 743 registrations outside the US
- Establishments
- 1France
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Biotech Dental Smilers, SAS 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 | Biotech Dental Smilers, SAS | 1 clearances | 2021–2021 | Below |
| Canada | Health Canada | Registration holder | BIOTECH DENTAL SMILERS | 31 | 2018–2018 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Biotech Dental Smilers SAS | 4 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | BIOTECH DENTAL SMILERS | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Biotech Dental Smilers, SASBIOTECH DENTAL SMILERS | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Biotech Dental Smilers | 1 | 2025–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BIOTECH DENTAL SMILERS S.A.S | 1 | 2026–2026 | 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 Biotech Dental Smilers, SAS currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | SMILERS | 2025 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Y-BRUSH | 2026 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | FROGGYMOUTHMYOSIMPLESMILERS | 2025 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Smilers | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Biotech Dental Smilers, SAS as the applicant.
Some of these clearances are listed with FDA today by another company: Biotech Dental (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Biotech Dental Smilers, SASFDA reg. 3014701704 | Salon-de-Provence Bouches-du-Rhone, France | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084087). 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.