FDA.report

Bioclear

Primary DI
D9494150112
Brand
Bioclear
Company
Bioclear Matrix Systems
Model
Blaster
Device description
Convenience kit of blaster, powder, and disclosing solution.
Published
2023-08-17
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
false

Related Records

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9494150112PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental abrasive air jet system handpieceA hand-held, dental device that is a component of a dental abrasive air jet system and which is used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth or teeth. This device is connected to the control unit that regulates the sources of pressurized air and temperate water. The abrasive, typically in the form of a powder that, depending upon the design of the delivery method, can be contained within a receptacle in this device or a receptacle within the control unit, is mixed with the air and water as this passes through. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
059020838
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true

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D949303021C0Original Posterior Matrix B SeriesB302 Clear2023-09-11
D949303031B0Original Posterior Matrix B SeriesB303 Blue2023-09-11
D949303031C0Original Posterior Matrix B SeriesB303 Clear2023-09-11
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D949304011C0Original Posterior Matrix M SeriesM401 Clear2023-09-11