Catalog Number

PLU13G

Brand Name

ProTech Plus Hard Reline and Repair Acrylic

Version/Model Number

PLU13G

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 07, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K151646

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Public Device Record Key

1c602365-ac61-46cb-9ff5-678c56c373bd

Public Version Date

May 17, 2019

Public Version Number

5

DI Record Publish Date

August 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-