Graphenano Dental, SL

Paterna Valencia, ES

GRAPHENANO DENTAL, SL appears in FDA device records in Paterna Valencia, ES. FDA records list 2 510(k) clearances between 2022-08-16 and 2025-09-29, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Graphenano Dental, SL between 2022 and 2025. The busiest year on record is 2022, with 1. The most recent is 2025, with 1.

Clearances by year, as a table

510(k) clearance decisions for Graphenano Dental, SL, by decision year
Year	Clearances
2022	1
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K253236	G-BLOCK	EBF	Substantially Equivalent	2025-09-29
K220329	G-CAM	EBF	Substantially Equivalent	2022-08-16

Registered establishments

FDA registered establishments for Graphenano Dental, SL, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3017183443	3017183443	GRAPHENANO DENTAL, SL	Poligono Industrial Tactica Calle 2A No 1, Paterna Valencia(Province) 46980 ES	2026	EBF EBG EBI

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1192-2024	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 GC00113; f) 95 Multichroma 16LB2, REF GC00131; g) 95 Multichroma 14LA2, REF GC00157; h) 95 Multichroma 20LB2, REF GC00098; i) 95 Multichroma 20LBL2, REF GC00114; j) 95 Multichroma 16LA3,5, REF GC00132; k) 95 Multichroma 14LA1, REF GC00158; l) 95 Multichroma 24LB1, REF GC00099; m) 95 Multichroma 20LA3,5, REF GC00115; n) 95 Multichroma 16LA3, REF GC00133; o) 95 Multichroma 16LC2, REF GC00091; p) 95 Multichroma 14LBL2, REF GC00134; q) 95 Multichroma 24LBL2, REF GC00092; r) 95 Multichroma 24LA3,5, REF GC00101; s) 95 Multichroma 20LA3, REF GC00117; t) 95 Multichroma 14LB1, REF GC00135; u) 95 Multichroma 24LB2, REF GC00094; v) 95 Multichroma 20LA2, REF GC00119; w) 95 Multichroma14LA3,5, REF GC00137; x) 95 Multichroma 14LC2, REF GC00095; y) 95 Multichroma 24LA3, REF GC00104; z) 95 Multichroma14LA3, REF GC00138 ; used in the manufacture of dentures.	Machining error on cams renders the device unusable.	Class II	2023-10-24	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain