Catalog Number

010.4035

Brand Name

Vita CAD-Temp For Inlab

Version/Model Number

Bridges (tooth borne)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

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

K070991

Product Code

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Public Device Record Key

af792160-7d0c-4da5-8a71-2c2b5d2ea6e0

Public Version Date

July 31, 2019

Public Version Number

1

DI Record Publish Date

July 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-