Catalog Number

H-4011P

Brand Name

Pro-V, Coat IntraOral MakerPkg

Version/Model Number

H-4011P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 17, 2022

Issuing Agency

In HIBCC

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

K103514

Product Code

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Public Device Record Key

0259183a-4a84-47ec-87bd-9d283160ad11

Public Version Date

January 31, 2022

Public Version Number

5

DI Record Publish Date

June 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-