FDA.reportPublic FDA data

inspiro Mini Kit Esthetic Anterior

Primary DI
07640163050059
Brand
inspiro Mini Kit Esthetic Anterior
Company
EDELWEISS DR ag
Model
3050
Device description
inspiro Mini Kit Esthetic Anterior
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640163050059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640163050059076401630500597640163050059

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
07640163050011inspiro Master Kit Compule 30102016-10-12
07640163050028inspiro Master Kit Syringe30202016-10-12
07640163050035inspiro Intro Kit Compule 30302016-10-12
07640163050042inspiro Intro Kit Syringe 30402016-10-12
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