Vera PDI - Vera PDI Hard, Dental casting non-noble alloy - AALBA DENT INC.

Duns Number:073944274

Device Description: Vera PDI Hard, Dental casting non-noble alloy

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More Product Details

Catalog Number

-

Brand Name

Vera PDI

Version/Model Number

PDIH

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

K915249

Product Code Details

Product Code

EJH

Product Code Name

Alloy, Metal, Base

Device Record Status

Public Device Record Key

db357329-f78e-457c-819c-f72b5e43b492

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 11, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AALBA DENT INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 41