IS-2000 - Bite Registration Material, Fast Set - ADA PRODUCTS CO, INC

Duns Number:624504028

Device Description: Bite Registration Material, Fast Set

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More Product Details

Catalog Number

-

Brand Name

IS-2000

Version/Model Number

40116

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

K951075

Product Code Details

Product Code

ELW

Product Code Name

Material, Impression

Device Record Status

Public Device Record Key

3a09c255-27ce-4f6f-8c91-f342987bd8ac

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 10, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADA PRODUCTS CO, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 17