O-Cryl Self Curing Acrylic Shade Clear With Glitter X 1 lb - O-Cryl Self Curing Acrylic Shade Clear With - PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A

Duns Number:880141023

Device Description: O-Cryl Self Curing Acrylic Shade Clear With Glitter X 1 lb

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More Product Details

Catalog Number

107788

Brand Name

O-Cryl Self Curing Acrylic Shade Clear With Glitter X 1 lb

Version/Model Number

107788

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

-

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

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Device Record Status

Public Device Record Key

1cf0d92f-39b5-4bf4-9400-165df9da6d05

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

May 23, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 94