Kera-Disc 99,5 x 12 mm - NEW - NPM - Cobalt-based dental alloy for - Eisenbacher Dentalwaren ED GmbH

Duns Number:344231006

Device Description: NEW - NPM - Cobalt-based dental alloy for milling, type 4, Dimension: 99,5 mm x 12 mm

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More Product Details

Catalog Number

-

Brand Name

Kera-Disc 99,5 x 12 mm

Version/Model Number

D10041112

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

EJH

Product Code Name

Alloy, Metal, Base

Device Record Status

Public Device Record Key

231a87c2-1d04-4945-bffa-4c0f5d0fb0b2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 11, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EISENBACHER DENTALWAREN ED GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 87