Data / Medical devices / Italy / 3diemme SRL
3diemme SRL: FDA-registered device maker in Cantu Como, Italy, 2 510(k) clearances
3diemme SRL is registered with the FDA (registration 3015173183) in Cantu Como, Italy. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 4, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015173183
- Address
- Via Risorgimento 9, Cantu Como, Italy, 22063
- Owner or operator
- 3DIEMME Srl (10059505)
- Roles
- Manufacturer
- First device listed
- January 29, 2019
- Registered through
- 2026
- Brand names listed
- AIS 3D app, ANCHOR PINS, BONE CREST LEVELER, DRILL, DRILL BIT, EVOBITE, MOUTH OPENING GAUGE, RealGUIDE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 4, 2026 | K253902 | RealGUIDE | QIH | Substantially Equivalent | 3DIEMME SRL | accessdata.fda.gov |
| December 20, 2018 | K173041 | 3DIEMME RealGUIDE | LLZ | Substantially Equivalent | 3Diemme , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Impression, Preformed
- All makers of Tray, Surgical, Instrument
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
- All makers of Accessories, Implant, Dental, Endosseous
Updated August 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.