FDA.report

HeatSync

Primary DI
D9494170131
Brand
HeatSync
Company
Bioclear Matrix Systems
Model
Mini
Device description
Warmer for composite used in dental restorations.
Published
2023-08-10
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
D9494170131PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental material heaterAn electrically-powered device designed to be used to heat, through conduction, a variety of materials/substances (e.g., composite resin, root canal cleaning solution, local anaesthetic agent) to facilitate application of the material (e.g., optimum performance, patient comfort) during a dental procedure. It consists of a heating element with a temperature controller and a heater plate.

Sterilization Methods

Method
High-level Disinfectant

Regulatory Flags

DUNS number
059020838
Device count
1
DM exempt
false
Premarket exempt
true
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
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D949303031C0Original Posterior Matrix B SeriesB303 Clear2023-09-11
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D949304011C0Original Posterior Matrix M SeriesM401 Clear2023-09-11