FDA.reportPublic FDA data

Ormaplus lab

Primary DI
08056640081666
Brand
Ormaplus lab
Company
MAJOR PRODOTTI DENTARI SPA
Model
LAB 90 - 4X 5KG
Catalog number
M4020
Device description
Addition-curing silicone for dental laboratory use. ORMAPLUS LAB 90 - 4X 5KG.
Published
2026-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056640081666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056640081666080566400816668056640081666

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
459034567
Device count
1
DM exempt
false
Premarket exempt
true
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
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
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
08056640082014Ormalab 955KG + 2 CAT 60MLM95202026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082601Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082991AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083042AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083080AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083134AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083141AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083196AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083202AlginkidMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083257AlginkidMAJOR PRODOTTI DENTARI SPAELW2026-10-20