FDA.reportPublic FDA data

inspiro Master Kit Compule

Primary DI
07640163050011
Brand
inspiro Master Kit Compule
Company
EDELWEISS DR ag
Model
3010
Device description
inspiro Master Kit Compule
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640163050011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640163050011076401630500117640163050011

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental composite resin kitA collection of customized equipment and supplies intended to be used to apply/polymerize composite resins to fill dental cavities or restore damaged dental tissue. It includes the composite resin, which may be self-, light-, or dual-cured, and additional devices which typically include a dental syringe, a mixing palette, a mixing pad, and brushes; it is customized for a specific patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
486793370
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640163050028inspiro Master Kit Syringe30202016-10-12
07640163050035inspiro Intro Kit Compule 30302016-10-12
07640163050042inspiro Intro Kit Syringe 30402016-10-12
07640163050059inspiro Mini Kit Esthetic Anterior 30502016-10-12
07640163050066inspiro Mini Kit General 30552016-10-12
07640163050080inspiro Effect Shade Ice 38102016-10-19
07640163050097inspiro Compule Trial Kit 30702016-10-19
07640163050110inspiro Body i0 32002016-10-19
07640163050127inspiro Body i1 32102016-10-19
07640163050134inspiro Body i1 32152016-10-19
07640163050141inspiro Body i2 32202016-10-19
07640163050158inspiro Body i2 32252016-10-19
07640163050165inspiro Body i3 32302016-10-19
07640163050172inspiro Body i3 32352016-10-19
07640163050189inspiro Body i4 32402016-10-19
07640163050196inspiro Body i4 32452016-10-19
07640163050202inspiro Body i5 32502016-10-19
07640163050219inspiro Skin Bleach 33002016-10-19
07640163050226inspiro Skin Bleach 33052016-10-19
07640163050233inspiro Skin White 33102016-10-19

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Primary DI, Brand, Company table
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08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
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