RH - Dental alloy restorations - AURIDENT INC

Duns Number:030580955

Device Description: Dental alloy restorations

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More Product Details

Catalog Number

-

Brand Name

RH

Version/Model Number

0.9 ozt

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

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

EJT

Product Code Name

Alloy, Gold-Based Noble Metal

Device Record Status

Public Device Record Key

50eefe1b-64ee-4f6a-a599-2e51eeb60b5c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 07, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AURIDENT INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 519