FDA.reportPublic FDA data

major.repair

Primary DI
08056640078857
Brand
major.repair
Company
MAJOR PRODOTTI DENTARI SPA
Model
STANDARD-SET MV
Catalog number
C3121-MV
Device description
Self-curing acrylic resin for denture relining, repairing and rebasing in dental prosthesis. Poly-methylmethacrylate (PMMA) based powder and liquid system, supplied in Standard-Set configuration. Shade MV. Classified as ISO 20795-1:2013 Type 2 Class 1. Single-use, non-sterile device intended for professional use by dental laboratory technicians and dental practitioners.
Published
2026-04-27
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
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082153000MAJOR.REPAIRMajor Prodotti Dentari S.P.A.2008-11-25EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056640078857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056640078857080566400788578056640078857

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Protect from sunlight

Contacts#

Phone, Email table
PhoneEmail
+390116400211quality@majordental.com

Regulatory Flags#

DUNS number
459034567
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056640076792temporary.cold.vSTANDARD SET B41002026-04-27
08056640078369major.base 20STANDARD-SET MVC3021-MV2026-04-27
08056640034310SUPER LUX A1-D4 X8 LOWER A2-1/65Shade A2, Mould 1/65T30122019-10-08
08056640034327SUPER LUX A1-D4 X8 UPPER A2-1/65Shade A2, Mould 1/65T30122019-10-08
08056640034334SUPER LUX A1-D4 X8 LOWER A2-70NShade A2, Mould 70NT30122019-10-08
08056640034341SUPER LUX A1-D4 X8 UPPER A2-70NShade A2, Mould 70NT30122019-10-08
08056640034358SUPER LUX A1-D4 X8 LOWER A2-1/72Shade A2, Mould 1/72T30122019-10-08
08056640034365SUPER LUX A1-D4 X8 UPPER A2-1/72Shade A2, Mould 1/72T30122019-10-08
08056640034372SUPER LUX A1-D4 X8 LOWER A2-1/74Shade A2, Mould 1/74T30122019-10-08
08056640034389SUPER LUX A1-D4 X8 UPPER A2-1/74Shade A2, Mould 1/74T30122019-10-08
08056640034396SUPER LUX A1-D4 X8 LOWER A2-76NShade A2, Mould 76NT30122019-10-08
08056640034402SUPER LUX A1-D4 X8 UPPER A2-76NShade A2, Mould 76NT30122019-10-08
08056640034419SUPER LUX A1-D4 X8 LOWER A2-77NShade A2, Mould 77NT30122019-10-08
08056640034426SUPER LUX A1-D4 X8 UPPER A2-77NShade A2, Mould 77NT30122019-10-08
08056640034433SUPER LUX A1-D4 X8 LOWER A2-79NShade A2, Mould 79NT30122019-10-08
08056640034440SUPER LUX A1-D4 X8 UPPER A2-79NShade A2, Mould 79NT30122019-10-08
08056640034457SUPER LUX A1-D4 X8 LOWER A2-A32Shade A2, Mould A32T30122019-10-08
08056640034464SUPER LUX A1-D4 X8 UPPER A2-A32Shade A2, Mould A32T30122019-10-08
08056640034471SUPER LUX A1-D4 X8 LOWER A2-A33Shade A2, Mould A33T30122019-10-08
08056640034488SUPER LUX A1-D4 X8 UPPER A2-A33Shade A2, Mould A33T30122019-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
EPRC66100851dima Print Denture Base 2pro3dure medical GmbHEBI2025-07-31
08435288443584IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443591IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443614IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443645IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443669IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443690IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443607IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443621IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443638IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443652IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443676IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
EPOLPMMP10090Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10100Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10110Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10120Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10130Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10140Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10150Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10160Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10170Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10180Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10190Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10200Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10210Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10220Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17