ACTEON - "The MINI DOCK USB2 module is built-in docking - SOPRO

Duns Number:264205501

Device Description: "The MINI DOCK USB2 module is built-in docking station for SOPROCARE, SOPROLIFE, SOPRO 617 "The MINI DOCK USB2 module is built-in docking station for SOPROCARE, SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. Thisproduct is designed for dental applications and is not intended for diagnosis."

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More Product Details

Catalog Number

S_717_1601

Brand Name

ACTEON

Version/Model Number

MINI DOCK USB2 STRAUMANN

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

-

Product Code Details

Product Code

NYH

Product Code Name

Plaque Disclosing Kit

Device Record Status

Public Device Record Key

e17fb85f-7808-4360-bb56-0c6353a939d6

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

March 12, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOPRO" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 128