Data / Medical devices / Italy / HDC S.R.L.
HDC S.R.L.: FDA-registered device maker in THIENE Vicenza, Italy, 3 510(k) clearances
HDC S.R.L. is registered with the FDA (registration 3005728057) in THIENE Vicenza, Italy. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 30, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005728057
- Address
- Via Dei Mestieri 5/7, THIENE Vicenza, Italy, 36016
- Owner or operator
- HDC S.R.L. (9077262)
- Roles
- Manufacturer
- First device listed
- April 28, 2006
- Registered through
- 2026
- Brand names listed
- Orthodontic Anchorage Attachment, SPIDER SCREW, STERILE SPIDER SCREW, Sterile Self Ligating Spider Screw
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Preformed, Orthodontic | ECM | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | 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 |
|---|---|---|---|---|---|---|
| July 30, 2009 | K091390 | HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 | OAT | Substantially Equivalent | Hdc S.R.L. | accessdata.fda.gov |
| October 18, 2007 | K071851 | HDC STERILE SPIDER SCREW | DZE | Substantially Equivalent | Hdc S.R.L. | accessdata.fda.gov |
| December 23, 2005 | K052471 | HDC SPIDER SCREW | DZE | Substantially Equivalent | Hdc S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Band, Preformed, Orthodontic
- All makers of Implant, Endosseous, Orthodontic
- All makers of Implant, Endosseous, Root-Form
Updated July 30, 2009. 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.