vynacron dental resins - denture resin - VYNACRON DENTAL RESINS INC

Duns Number:080952401

Device Description: denture resin

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More Product Details

Catalog Number

-

Brand Name

vynacron dental resins

Version/Model Number

25OC

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)

-

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

3af65ca1-f315-4d9e-af1f-61c3c2015273

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

August 08, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VYNACRON DENTAL RESINS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 46