Catalog Number

50ml/bio-cartridge, 2 bio-cartridges/box

Brand Name

Elastomeric Impression Material

Version/Model Number

Type 0 (Bite Registration Dispenser-mix Normal Set)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K133071

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

de731552-716d-49ce-b20b-670bb8b1b8f4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-