N.A. - Silichrom polisher, coarse grain size, Form: - DENTAURUM GmbH & Co.KG

Duns Number:315427286

Device Description: Silichrom polisher, coarse grain size, Form: cylindrical, front and side cutting

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More Product Details

Catalog Number

-

Brand Name

N.A.

Version/Model Number

138-645-00

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

EJQ

Product Code Name

WHEEL, POLISHING AGENT

Device Record Status

Public Device Record Key

fb4edd81-28c4-47ca-8fa9-5d945c543212

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTAURUM GMBH & CO.KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2768
2 A medical device with a moderate to high risk that requires special controls. 1745