Drill Stopper for Long L15/Short L10 1846 - ADIN DENTAL IMPLANT SYSTEMS LTD

Duns Number:533289435

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More Product Details

Catalog Number

-

Brand Name

Drill Stopper for Long L15/Short L10 1846

Version/Model Number

S1846L15

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

EJL

Product Code Name

Bur, Dental

Device Record Status

Public Device Record Key

294ada4f-f233-447a-9bbd-02b96a8d93d3

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

April 23, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADIN DENTAL IMPLANT SYSTEMS LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 483
2 A medical device with a moderate to high risk that requires special controls. 892