Data / Medical devices / Spain / Graphenano Dental, SL

Graphenano Dental, SL: FDA-registered device maker in Paterna Valencia(Province), Spain, 2 510(k) clearances

Name: Graphenano Dental, SL FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Graphenano Dental, SL is registered with the FDA (registration 3017183443) in Paterna Valencia(Province), Spain. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 29, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017183443
Address: Poligono Industrial Tactica Calle 2A No 1, Paterna Valencia(Province), Spain, 46980
Owner or operator: Graphenano Dental, SL (10084283)
Roles: Complaint file establishment, Exporter to the US, Manufacturer
First device listed: October 13, 2022
Registered through: 2026
Brand names listed: G-CAM, GRAPHENANO DENTAL

Devices it lists

Device	Product code	Class	Role	Source
Crown And Bridge, Temporary, Resin	EBG	2	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	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
September 29, 2025	K253236	G-BLOCK	EBF	Substantially Equivalent	Graphenano Dental S.L.	accessdata.fda.gov
August 16, 2022	K220329	G-CAM	EBF	Substantially Equivalent	Graphenano Dental S.L.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 24, 2023	93943	Class II	Ongoing	GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF	Machining error on cams renders the device unusable.	accessdata.fda.gov

Compare with other makers

Updated September 29, 2025. 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.