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
08056640080997Ormadent Putty1,5KG / 900MLM10002026-10-20
08056640081093Ormactivator60MLM10922026-10-20
08056640081109Ormactivator60MLM10942026-10-20
08056640081161Ormamax150MLM20002026-10-20
08056640081185Ormamax150MLM20102026-10-20
08056640081598Ormaplus labLAB 90 - 0,9+0,9 KGM40002026-10-20
08056640081604Ormaplus labLAB 90 - ORMAPLUS LAB 90 SAMPLE- 0,6KGM40032026-10-20
08056640081611Ormaplus labLAB 90 - 2,5+2,5 KGM40052026-10-20
08056640081642Ormaplus labLAB 90 - 5+5 KGM40102026-10-20
08056640081666Ormaplus labLAB 90 - 4X 5KGM40202026-10-20
08056640081673Ormaplus labLAB 90 - 10+10 KGM40212026-10-20
08056640081734Ormaplus labLAB 70 - 0,75+0,75 KGM43002026-10-20
08056640081741Ormaplus labLAB 70 - 5+5 KGM43102026-10-20
08056640081802Ormalab 751,6KG / 900MLM75002026-10-20
08056640081819Ormalab 755KGM75102026-10-20
08056640081826Ormalab 7510KGM75152026-10-20
08056640081833Ormalab 755KG + 2 CAT 60MLM75202026-10-20
08056640081925Ormalab 855KG + 2CATM85202026-10-20
08056640081994Ormalab 951,6KG / 900MLM95002026-10-20
08056640082007Ormalab 955KGM95102026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06942480707809FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707823FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707830FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942201776305FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788100FLNT 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
06942201788780FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
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06942201789152FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
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06942201789183FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
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06942201789350FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789442FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789459FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
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06942480707625FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17