FDA.reportPublic FDA data

G-BLOCK

Primary DI
08445644003482
Brand
G-BLOCK
Company
GRAPHENANO DENTAL SL.
Model
GB00028
Device description
40LA1
Published
2026-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253236000G-BLOCKGraphenano Dental S.L.2025-09-29EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08445644003482PrimaryGS10
08445644003840Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08445644003482084456440034828445644003482
08445644003840084456440038408445644003840

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+34965108102info@graphenano.com

Regulatory Flags#

DUNS number
467167850
Device count
3
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08445644003246G-BLOCKGB000042026-01-14
08445644003253G-BLOCKGB000052026-01-14
08445644003260G-BLOCKGB000062026-01-14
08445644003277G-BLOCKGB000072026-01-14
08445644003284G-BLOCKGB000082026-01-14
08445644003291G-BLOCKGB000092026-01-14
08445644003307G-BLOCKGB000102026-01-14
08445644003314G-BLOCKGB000112026-01-14
08445644003321G-BLOCKGB000122026-01-14
08445644003338G-BLOCKGB000132026-01-14
08445644003345G-BLOCKGB000142026-01-14
08445644003352G-BLOCKGB000152026-01-14
08445644003369G-BLOCKGB000162026-01-14
08445644003376G-BLOCKGB000172026-01-14
08445644003383G-BLOCKGB000182026-01-14
08445644003512G-BLOCKGB000312026-01-14
08445644003529G-BLOCKGB000322026-01-14
08445644003536G-BLOCKGB000332026-01-14
08445644003543G-BLOCKGB000342026-01-14
08445644003550G-BLOCKGB000352026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208477825Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-10-19
07615208477832Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-10-19
06942201776305FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
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06942201788483FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
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06942201788773FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
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06942201789541FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
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06942480707915FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707939FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480708004FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
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06942480708103FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17