VINTAGE PRO BODY D2B 50G - VINTAGE PRO BODY D2B 50G - SHOFU DENTAL CORPORATION

Duns Number:054618202

Device Description: VINTAGE PRO BODY D2B 50G

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More Product Details

Catalog Number

P0164

Brand Name

VINTAGE PRO BODY D2B 50G

Version/Model Number

P0164

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

K181496

Product Code Details

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Device Record Status

Public Device Record Key

0bfc3c98-b5d1-4745-b7db-02717669ae0b

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