Manufacturer registered with FDA

Hdc S.R.L.

thiene, Italy. Lists 3 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.

FDA owner/operator9077262Manufacturer

Device types listed: 3
Brands and models: 4
510(k) clearances: 32005–2009
Markets registered in: 1United States
Establishments: 1Italy

510(k) clearances per year, 2000–2026

Devices listed with FDA

What Hdc S.R.L. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	SPIDER SCREWSTERILE SPIDER SCREW	2006
Orthodontic Preformed BandECM · Class 1	Orthodontic wires & bands	Maker	Orthodontic Anchorage Attachment	2010
Orthodontic Endosseous ImplantOAT · Class 2	—	Maker	Sterile Self Ligating Spider Screw	2009

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 Hdc S.R.L. as the applicant.

Decided	510(k)	Device	Device type
30 Jul 2009	K091390	HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2	OAT Orthodontic Endosseous Implant
18 Oct 2007	K071851	HDC STERILE SPIDER SCREW	DZE Root-Form Endosseous Implant
23 Dec 2005	K052471	HDC SPIDER SCREW	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
HDC S.R.L.FDA reg. 3005728057	THIENE Vicenza, Italy	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9077262). 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.