Manufacturer registered with FDA
ASA Dental
BOZZANO, Italy. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 10397 registrations outside the US
- Establishments
- 1Italy
Registered in 10 markets
Where regulators' registries name ASA Dental 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 | ASA Dental | 12 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | ASA DENTAL S.P.A. | 222 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Asa Dental S.p.A. | 76 | — | Pure Global AI |
| Australia | TGA | Manufacturer | ASA DentalASA Dental SPA | 50 | 2004–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | ASA DENTAL S.p.AASA DENTAL S.p.A. · Asa Dental S.p.A. · +2 | 26 | 1999–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ASA DENTAL S.P.A.ASA DENTAL S.P.A | 9 | 2006–2021 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | ASA DENTAL SPA | 5 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | ASA DENTAL S.P.A. | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Asa Dental S.P.A.Asa Dental S.p.A. · Asa Dental Spa | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | ASA DENTAL S.P.A. | 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 ASA Dental 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 DISPOSABLE | 1994 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental Hand Instruments | 2008 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mouth Mirror | 2001 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | Rubber Dam Clamp | 2010 |
| Roll CottonEFN · Class 1 | — | Maker | Cotton Roll | 2008 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | DAPPEN DISHES | 2005 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression Trays | 1986 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | SCAN SYRINGE | 2005 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | PROBE | 2002 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic Plier | 1993 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | Facebow | 2012 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Patient bibs; polytowels | 2008 |
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 |
|---|---|---|
| ASA DENTAL S.P.A.FDA reg. 8021050 | MARLIA Lucca, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8021050). 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.