ACTEON - "In mode I, diagnosis aid mode, SOPROLIFE helps - SOPRO

Duns Number:264205501

Device Description: "In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage a "In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution.In mode II, treatment aid mode, SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect.In daylight mode », SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror. It allows the dentist to show the difference between «before» and «after» care."

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More Product Details

Catalog Number

S_900_0009

Brand Name

ACTEON

Version/Model Number

SOPROLIFE NTSC

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

NBL

Product Code Name

Laser,Fluorescence Caries Detection

Device Record Status

Public Device Record Key

bd313e3f-d808-4eea-88da-d279e3bc7efc

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

March 13, 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