FDA.reportPublic FDA data

Bioclear Evolve Posterior Kit

Primary DI
D9498270612
Brand
Bioclear Evolve Posterior Kit
Company
Bioclear Matrix Systems
Model
Starter
Device description
Convenience kit of Bioclear products used in posterior dental restorations.
Published
2023-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9498270612PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band kitA collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
059020838
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D9498010162Black Triangle (BT) KitStudent/EM2024-12-03
D9498271712Evolve All-in-One Select KitFull2024-12-03
D9498271612Evolve All-in-One Select KitStudent/EM2024-10-22
D9499000412BT, Evolve, & DWSamples for 3M Heaters2024-08-20
D9498270912Evolve Matrix Procedure KitBrazil2024-07-10
D9495000821Bioclear InstrumentTwinRing Forceps2024-04-05
D9498271312Select Bioclear Evolve Posterior KitSelect2024-04-05
D9498271412Bioclear Evolve Posterior KitSelect Add-On Kit2024-04-05
D949112011021Bioclear Diamond WedgeSmall2023-09-16
D949112011041Bioclear Diamond WedgeSmall2023-09-16
D949112011081Bioclear Diamond WedgeSmall2023-09-16
D949112011101Bioclear Diamond WedgeSmall2023-09-16
D949112011161Bioclear Diamond WedgeSmall2023-09-16
D949112011500BG1Bioclear Diamond WedgeSmall2023-09-16
D949112011503Bioclear Diamond WedgeSmall2023-09-11
D94911201150BG1Bioclear Diamond WedgeSmall2023-09-16
D949112021021Bioclear Diamond WedgeMedium2023-09-16
D949112021041Bioclear Diamond WedgeMedium2023-09-16
D949112021081Bioclear Diamond WedgeMedium2023-09-16
D949112021101Bioclear Diamond WedgeMedium2023-09-16