Yamahachi Pink CAD/CAM Disk (JUSTI) - YAMAHACHI DENTAL MFG.,CO.

Duns Number:693430001

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More Product Details

Catalog Number

-

Brand Name

Yamahachi Pink CAD/CAM Disk (JUSTI)

Version/Model Number

20mm, LIGHT REDDISH PINK

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172683

Product Code Details

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Device Record Status

Public Device Record Key

1bac6b41-1032-460a-bc3c-969295b3025c

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

August 05, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"YAMAHACHI DENTAL MFG.,CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 3443