FDA.reportPublic FDA data

inspiro Body i2

Primary DI
07640163050158
Brand
inspiro Body i2
Company
EDELWEISS DR ag
Model
3225
Device description
inspiro Body i2 20 x 0.3 g Compule
Published
2016-10-19
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
07640163050158PrimaryGS10
76401630503225Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640163050158076401630501587640163050158
7640163050322576401630503225

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
20
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08685313736208DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBF2026-08-25
08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBF2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBF2026-08-25
08809518345663One-Temp FlowMEDICLUS CO.,LTDEBF2026-08-12
08809518345670One-Temp FlowMEDICLUS CO.,LTDEBF2026-08-12
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
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07615208476811Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476828Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476835Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476842Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477658Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477665Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477672Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477689Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477696Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477702Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29