FDA.reportPublic FDA data

PLASTALGIN

Primary DI
03760140703403
Brand
PLASTALGIN
Company
SEPTODONT SAS SPECIALITES SEPTODONT
Model
01C1000
Catalog number
01C1000
Device description
QUICK SET IMPRESS MATERIAL
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
03760140703403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760140703403037601407034033760140703403

GMDN Terms#

Term, Definition table
TermDefinition
Alginate dental impression materialA material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight454Gram

Regulatory Flags#

DUNS number
275273795
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303620001434Septodont Multi-Use Dispenser01C20562025-05-29
14719871634322Biodentine Mixer01C072501C07252025-04-25
03760140703359RACEGEL01C050001C05002016-09-12
03760140703243CIMPAT PINK01E011001E01102016-09-12
03760140703250CIMPAT WHITE01E012001E01202016-09-12
07897990328435SeptoWedges Refill: 100 Asst. wooden wedges01C402001C40202022-12-19
07897990328459SeptoMatrix Sectional Refill: 50 assorted matrices01C401401C40142022-12-16
07897990328466SeptoMatrix Sectional Refill: 50 large matrices01C401501C40152022-12-16
07897990328473SeptoMatrix Sectional Refill: 50 medium matrices01C401601C40162022-12-16
07897990328480SeptoMatrix Sectional Refill: 50 small matrices01C401701C40172022-12-16
07897990328718SeptoPlus Mandrel Refill: 1 mandrel snap01C403101C40312022-12-19
07897990328725SeptoDiscs Kit: 120 assorted abrasive discs+ mandrel pop-on01C400101C40012022-12-16
07897990328732SeptoDiscs Refill:1/2” 50 assorted abrasive discs01C400201C40022022-12-16
07897990328749SeptoDiscs Refill:1/2” 50 coarse abrasive discs01C400301C40032022-12-16
07897990328756SeptoDiscs Refill:1/2” 50 medium abrasive discs01C400401C40042022-12-16
07897990328763SeptoDiscs Refill: 1/2” - 50 fine abrasive discs01C400501C40052022-12-16
07897990328770SeptoDiscs Refill: 1/2” - 50 extra fine abrasive discs01C400601C40062022-12-16
07897990329081SeptoWedges Refill: 100 wooden wedges n°1-yellow01C402101C40212022-12-19
07897990329098SeptoWedges Refill: 100 wooden wedges n°2-blue01C402201C40222022-12-19
07897990329104SeptoWedges Refill: 100 wooden wedges n°3-red01C402301C40232022-12-19

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