Catalog Number

(400g base+400g catalyst+50ml/bio-cartridge)/box

Brand Name

Elastomeric Impression Material

Version/Model Number

Type 0 (Putty Hand-Mix)+Type 3 (Light Body)

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

673ff7d0-9429-4dd3-b281-eb6fed58a5b1

Public Version Date

November 16, 2018

Public Version Number

1

DI Record Publish Date

October 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-