FDA.reportPublic FDA data

temporary.cold.v

Primary DI
08056640076792
Brand
temporary.cold.v
Company
MAJOR PRODOTTI DENTARI SPA
Model
STANDARD SET
Catalog number
B4100
Device description
Self-curing acrylic resin for the fabrication of temporary crowns and bridges in dentistry. Poly-methylmethacrylate (PMMA) based powder and liquid system, supplied in Standard-Set configuration (6 powder jars of 100 g each and 2 liquid bottles of 100 mL each). Classified as ISO 10477:2020 Type 1. Single-use, non-sterile device intended for professional use by 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
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082700000TEMPORARY COLD.V AND SELF-CURE DENTINEMajor Prodotti Dentari S.P.A.2008-12-09EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056640076792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056640076792080566400767928056640076792

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridgeA prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

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
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
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
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA1270PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1350PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1430PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0470PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0550PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0630PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0710PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0790PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0870PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0950PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0070PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1030PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1110PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1190PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLKML200160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML200200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02