FDA.reportPublic FDA data

Bioclear Evolve

Primary DI
D9493272310
Brand
Bioclear Evolve
Company
Bioclear Matrix Systems
Model
Black 7mm
Device description
Clear matrix used in dental restorations.
Published
2023-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JEPRetainer, Matrix

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D949327231251PrimaryHIBCC0
D949327231501PrimaryHIBCC0
D9493272310Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band, single-useA band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
059020838
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10304040193911Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
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10686864060649MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
10686864060656MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
10810038090495Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090501Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090518Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090525Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090532Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090549Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090556Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
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20810038090522Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090539Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
M752ZZ14080STRADIS HEALTHCARESTRADIS MEDICAL, LLCJEP2022-04-29
10686864056482MEDICOM SAFEMATRIXAMD Medicom IncJEP2021-04-27
10686864056499MEDICOM SAFEMATRIX CONTOURAMD Medicom IncJEP2021-04-27
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10304040142803Henry ScheinHENRY SCHEIN, INC.JEP2021-03-12
10304040142827Henry ScheinHENRY SCHEIN, INC.JEP2021-03-12