Maxigold KF - Maxigold KF 5 g - IVOCLAR VIVADENT, INC.

Duns Number:176935203

Device Description: Maxigold KF 5 g

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More Product Details

Catalog Number

582058

Brand Name

Maxigold KF

Version/Model Number

582058

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

-

Product Code Details

Product Code

EJT

Product Code Name

Alloy, gold-based noble metal

Device Record Status

Public Device Record Key

d6f5bb63-a434-4282-8876-57a9d6d9ccb6

Public Version Date

April 27, 2022

Public Version Number

4

DI Record Publish Date

October 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IVOCLAR VIVADENT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 485