RS Wide Healing abutment 6mmd x 5mml - ADIN DENTAL IMPLANT SYSTEMS LTD

Duns Number:533289435

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More Product Details

Catalog Number

-

Brand Name

RS Wide Healing abutment 6mmd x 5mml

Version/Model Number

RS3015

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

Yes

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

K081751

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

817b88dd-8cdd-4375-aaa3-1e91e8866405

Public Version Date

December 07, 2018

Public Version Number

4

DI Record Publish Date

October 02, 2015

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