Manufacturer registered with FDA
Lascod Spa
FLORENCE, TUSCANY, Italy. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 53
- 510(k) clearances
- 22012–2020
- Markets registered in
- 1164 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Lascod Spa 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 | Lascod Spa | 2 clearances | 2012–2020 | Below |
| Colombia | INVIMA | Manufacturer | LASCOD S.P.ALASCOD S.P.A. | 16 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | LASCOD SpA | 9 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | LASCOD S.p.A. | 8 | 2015–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | LASCOD S.p.ALASCOD S.P.A · LASCOD SPA · +1 | 8 | 1999–2011 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Lascod Spa | 8 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | LASCOD SPA | 6 | 2004–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | LASCODLASCOD SPA · LASCOD S.P.A. | 5 | 2011–2021 | Pure Global AI |
| China | NMPA | Registration holder | 莱斯卡LASCOD S.P.A.莱斯卡公司LASCOD S.P.A. | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Lascod SPA | 1 | 2016–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | LASCOD S.p.A. | 1 | — | 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 Lascod Spa currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Maker | AlginelleAlginorGhenesyl Body Heavy Fast SetGhenesyl Body Heavy Normal SetGhenesyl Body Light Fast SetGhenesyl Body Light Normal SetGhenesyl Body Regular Fast SetGhenesyl Body Regular Normal SetGhenesyl Body Super Light Fast SetGhenesyl Body Super Light Normal Set 40 moreGhenesyl Fast Set Kit - Putty Hard + Light BodyGhenesyl Fast Set Kit - Putty Hard + Super Light BodyGhenesyl Fast Set Kit - Putty Soft + Light BodyGhenesyl Fast Set Kit - Putty Soft + Super Light BodyGhenesyl MonoGhenesyl Normal Set Kit - Putty Hard + Light BodyGhenesyl Normal Set Kit - Putty Soft + Light BodyGhenesyl Normal Set Kit- Putty Hard + Super Light BodyGhenesyl Normal Set Kit- Putty Soft + Super Light BodyGhenesyl Putty Hard Fast SetGhenesyl Putty Hard Normal SetGhenesyl Putty Soft Fast SetGhenesyl Putty Soft Normal SetIQKromopanKromopan Sil BiteKromopan Sil Body Heavy Fast SetKromopan Sil Body Heavy Normal SetKromopan Sil Body Light Fast SetKromopan Sil Body Light Normal SetKromopan Sil Body Regular Fast SetKromopan Sil Body Regular Normal SetKromopan Sil Body Super Light Fast SetKromopan Sil Body Super Light Normal SetKromopan Sil Fast Set Kit - Putty hard + Light BodyKromopan Sil Fast Set Kit - Putty Hard + Super Light BodyKromopan Sil Fast Set Kit - Putty Soft + Light BodyKromopan Sil Fast Set Kit - Putty Soft + Super Light BodyKromopan Sil MonoKromopan Sil Normal Set Kit - Putty Hard + Light BodyKromopan Sil Normal Set Kit - Putty Hard + Super Light BodyKromopan Sil Normal Set Kit - Putty Soft + Light BodyKromopan Sil Normal Set Kit - Putty Soft + Super Light BodyKromopan Sil Putty Hard Fast SetKromopan Sil Putty Hard Normal SetKromopan Sil Putty Soft Fast SetKromopan Sil Putty Soft Normal SetMilleniumMono7Oklurest | 2020 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Exploit | 2009 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Algisyr | 2011 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | ZEFFIRO | 1995 |
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 Lascod Spa as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 May 2020 | K201184 | Lascod Impression Materials | ELW Impression Material |
| 23 Aug 2012 | K121824 | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 | ELW Impression Material |
Some of these clearances are listed with FDA today by another company: HEXA Dental (1), American Orthodontics (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LA.SC.OD. SPAFDA reg. 8021059 | FLORENCE, TUSCANY Firenze, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8021059). 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.