Lubricare Maintenance System - Device used to maintain optimum performance and - Bien-Air Dental SA

Duns Number:480082080

Device Description: Device used to maintain optimum performance and prolong working life of dental handpieces. Device used to maintain optimum performance and prolong working life of dental handpieces. Delivers oli and air automatically to the handpiece and is used after dental treatement before autoclaving

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More Product Details

Catalog Number

1600915-001

Brand Name

Lubricare Maintenance System

Version/Model Number

1600915-001

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

79865eb6-ee15-48ae-8045-e0cafc3c2daf

Public Version Date

July 01, 2021

Public Version Number

1

DI Record Publish Date

June 23, 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