VINT ART UNIV BASIC COLOR SET - VINT ART UNIV BASIC COLOR SET - SHOFU DENTAL CORPORATION

Duns Number:054618202

Device Description: VINT ART UNIV BASIC COLOR SET

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More Product Details

Catalog Number

P0723

Brand Name

VINT ART UNIV BASIC COLOR SET

Version/Model Number

P0723

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

-

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

K191794

Product Code Details

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Device Record Status

Public Device Record Key

7acb086a-4c66-4093-a2c8-15b6d48ca65f

Public Version Date

February 11, 2021

Public Version Number

1

DI Record Publish Date

February 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHOFU DENTAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 691
2 A medical device with a moderate to high risk that requires special controls. 2950