JDIcon - Ball Abutment H 3.0 JDIcon - J DENTAL CARE SRL

Duns Number:428716597

Device Description: Ball Abutment H 3.0 JDIcon

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More Product Details

Catalog Number

ICBA30

Brand Name

JDIcon

Version/Model Number

Ball Abutment H 3.0 JDIcon

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

K182081

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

dbe77286-b53e-458d-92b1-c3c276eb0ec4

Public Version Date

August 05, 2020

Public Version Number

1

DI Record Publish Date

July 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"J DENTAL CARE SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 287
2 A medical device with a moderate to high risk that requires special controls. 200