FDA.reportPublic FDA data

major.base 20

Primary DI
08056640078338
Brand
major.base 20
Company
MAJOR PRODOTTI DENTARI SPA
Model
STANDARD-SET K
Catalog number
C3021-K
Device description
Heat-curing acrylic resin for the fabrication of denture bases in dental prosthesis. Poly-methylmethacrylate (PMMA) based powder and liquid system, supplied in Standard-Set configuration. Shade K. Classified as ISO 20795-1:2013 Type 1 Class 1. Single-use, non-sterile device intended for professional use by dental laboratory technicians.
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K081884000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081884000MAJOR.BASE 20Major Prodotti Dentari S.P.A.2008-10-08EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056640078338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056640078338080566400783388056640078338

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056640078321major.base 20STANDARD-SET IVC3021-IV2026-09-30
08056640078345major.base 20STANDARD-SET KVC3021-KV2026-09-30
08056640078352major.base 20STANDARD-SET MC3021-M2026-09-30
08056640078376major.base 20STANDARD-SET TC3021-T2026-09-30
08056640078802major.repairSTANDARD-SET IC3121-I2026-09-30
08056640078819major.repairSTANDARD-SET IVC3121-IV2026-09-30
08056640078826major.repairSTANDARD-SET KC3121-K2026-09-30
08056640078833major.repairSTANDARD-SET KVC3121-KV2026-09-30
08056640078840major.repairSTANDARD-SET MC3121-M2026-09-30
08056640080751major.base 20STANDARD-SET IC3021-I2026-09-30
08056640076792temporary.cold.vSTANDARD SET B41002026-04-27
08056640078369major.base 20STANDARD-SET MVC3021-MV2026-04-27
08056640078857major.repairSTANDARD-SET MVC3121-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056640078321major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078345major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078352major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078376major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078802major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078819major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078826major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078833major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078840major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640080751major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08720604634235Vertex-Dental BVVertex-Dental B.V.EBI2026-09-24
08720604634242Vertex-Dental BVVertex-Dental B.V.EBI2026-09-24
06971437943618UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943625UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943649UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943700UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943748UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
08685313736208DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
00883205041883UltraCemULTRADENT PRODUCTS, INC.EBI2026-08-22
07630813462523XPLEX BaseCandulor AGEBI2026-07-28
00850061175175Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175182Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175199Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
07615208585728Ivotion BaseIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585735IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585742IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585759IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585766IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08