WISE CLICK ATTACHMENT ABUTMENT - Wise Click Minor- Retained Over Denture Abutments - DENTIN IMPLANTS TECHNOLOGIES LTD

Duns Number:600215680

Device Description: Wise Click Minor- Retained Over Denture Abutments

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More Product Details

Catalog Number

-

Brand Name

WISE CLICK ATTACHMENT ABUTMENT

Version/Model Number

WCM-0030

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120530

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

1175419c-f770-4b8f-a610-9dbaf143437c

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

September 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTIN IMPLANTS TECHNOLOGIES LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 98
2 A medical device with a moderate to high risk that requires special controls. 496