Slimax-C Plus - Slimax-C Plus,Blue,Cordless, Display Panel, - Beyes Dental Canada Inc

Duns Number:244261462

Device Description: Slimax-C Plus,Blue,Cordless, Display Panel, Built-in Radiometer

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More Product Details

Catalog Number

-

Brand Name

Slimax-C Plus

Version/Model Number

SM1003P-B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K080025

Product Code Details

Product Code

EBZ

Product Code Name

Activator, Ultraviolet, For Polymerization

Device Record Status

Public Device Record Key

988bec31-6a43-4010-af5d-f73588bd3d9a

Public Version Date

October 13, 2022

Public Version Number

1

DI Record Publish Date

October 05, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEYES DENTAL CANADA INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 150
2 A medical device with a moderate to high risk that requires special controls. 17
U Unclassified 6