SET CHIROPRO 3RD GEN KM CA - Sets of Chiropro systems and their dental - Bien-Air Dental SA

Duns Number:480082080

Device Description: Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant acces Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories

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More Product Details

Catalog Number

1700737-001

Brand Name

SET CHIROPRO 3RD GEN KM CA

Version/Model Number

1700737-001

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

-

Product Code Details

Product Code

EBW

Product Code Name

Controller, foot, handpiece and cord

Device Record Status

Public Device Record Key

2a87930d-eaaa-4054-929b-8627f1da7a13

Public Version Date

June 25, 2021

Public Version Number

1

DI Record Publish Date

June 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIEN-AIR DENTAL SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 213