DBSWIN - Dental Imaging Software. Software Version 5.x.x. - DÜRR DENTAL SE

Duns Number:315563684

Device Description: Dental Imaging Software. Software Version 5.x.x.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

DBSWIN

Version/Model Number

E7200A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K190629

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

ebc3a1c6-e458-41e9-974d-31ce6421615d

Public Version Date

April 17, 2019

Public Version Number

1

DI Record Publish Date

April 09, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DÜRR DENTAL SE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 28