SIC invent Dental Implant Systems - SICvantage Gingiva Shaper blue, anterior, - SIC invent AG

Duns Number:482083990

Device Description: SICvantage Gingiva Shaper blue, anterior, concave, GH 1.0 mm

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More Product Details

Catalog Number

-

Brand Name

SIC invent Dental Implant Systems

Version/Model Number

950336

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

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

-

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

5315bcca-d6af-44d6-9957-1ec1c282b3cc

Public Version Date

December 07, 2018

Public Version Number

2

DI Record Publish Date

July 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIC INVENT AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 281