Neoloy® - Dentsply International Inc.

Duns Number:606173334

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More Product Details

Catalog Number

N151100

Brand Name

Neoloy®

Version/Model Number

N Regular

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 05, 2022

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)

-

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

eb9e5708-a508-4467-8d9b-523b0800afac

Public Version Date

May 06, 2022

Public Version Number

3

DI Record Publish Date

January 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTSPLY INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 57
2 A medical device with a moderate to high risk that requires special controls. 19532