Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017183443

FEI Number

3017183443

Entity Name

GRAPHENANO DENTAL, SL

City/State/Country

Paterna Valencia, ES

Establishment Address

Poligono Industrial Tactica Calle 2A No 1, Paterna Valencia 46980, ES

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Graphenano Dental, SL (Owner Number: 10084283)

Owner / Operator Contact Address

Carretera de Villena, Km. 0.5, Yecla, ES-MC 30510, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253236

PMA Number

N/A

All Registered Proprietary Names

G-CAM GRAPHENANO DENTAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2022-10-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-10-13
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2022-10-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-12-29

Official Correspondent

No official correspondent registered.

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: customerservices@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

Graphenano Dental, SL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017183443. Last updated year: 2026. Please use registration number 3017183443 when referencing this establishment in official correspondence.