Manufacturer registered with FDA
Orthodontic Manufacturer SIA SRL
ROCCA D'EVANDRO (CE), Italy. Lists 15 dental device types with FDA across 1 registered establishment.
- Device types listed
- 15
- Brands and models
- 39
- 510(k) clearances
- 0as applicant
- Markets registered in
- 535 registrations outside the US
- Establishments
- 1Italy
Registered in 5 markets
Where regulators' registries name Orthodontic Manufacturer SIA SRL 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 | Orthodontic Manufacturer SIA SRL | 15 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | ORTHODONTIC MANUFACTURER SIA SRL | 23 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | ORTHODONTIC MANUFACTURER SIA SRL | 5 | 2010–2010 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ORTHODONTIC MANUFACTURER SIA SRL | 4 | 2020–2023 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | ORTHODONTIC MANUFACTURER SIA S.R.L. | 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 Orthodontic Manufacturer SIA SRL 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 Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | LEONARDO PALATAL EXPANDERSIA ORTHODONTIC MANUFACTURERSMART CLICKXP PALATAL EXPANDER | 2012 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | SIA ORTHODONTIC MANUFACTURER | 2012 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | ACTIVAD-barSIA ORTHODONTIC MANUFACTURER | 2012 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Maker | SIA ORTHODONTIC MANUFACTURER | 2018 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | I-ARCHMACH3SIA ORTHODONTIC MANUFACTURER | 2012 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | JETJET LPSIA ORTHODONTIC MANUFACTURERZIP T6ZIP T7 | 2001 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | SIA ORTHODONTIC MANUFACTURER | 2001 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | SIA ORTHODONTIC MANUFACTURER | 2001 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | CRIMPABLE STOPSIA ORTHODONTIC MANUFACTURERSLIDING AND CRIMPABLE HOOKS | 2001 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | SIA ORTHODONTIC MANUFACTURER | 2012 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | SIA ORTHODONTIC MANUFACTURERSVOP | 2012 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | INTERPROXIMAL INCREMENTAL GAUGEIPRSIA ORTHODONTIC MANUFACTURER | 2016 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | BT2 - BITURBOHEXAGONMICROFITSIA ORTHODONTIC MANUFACTURERSUPERTECHTS2 -ZIPZIP LP | 2001 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | SIA ORTHODONTIC MANUFACTURER | 2012 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | FACEBOWSIA ORTHODONTIC MANUFACTURER | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Orthodontic Manufacturer SIA SRL lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: G&H Wire Company (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 Jul 1996 | K961754 | SAFETY RELEASE MODULE | G&H Wire Company | DZB Orthodontic Extraoral Headgear |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORTHODONTIC MANUFACTURER SIA SRLFDA reg. 9710113 | ROCCA D EVANDRO Caserta, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9080887). 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.