PM 1:1 Ext Spray - CA and HP are intended to transmit and apply the - Bien-Air Dental SA

Duns Number:480082080

Device Description: CA and HP are intended to transmit and apply the mechanical energy produced by a dental ai CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed

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More Product Details

Catalog Number

1600052-001

Brand Name

PM 1:1 Ext Spray

Version/Model Number

1600052-001

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

EFB

Product Code Name

Handpiece, air-powered, dental

Device Record Status

Public Device Record Key

93d53c82-69de-45b7-8fa7-4fcb347cb143

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