Catalog Number

LRH12

Brand Name

ProTech Soft Reline

Version/Model Number

LRH12

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 16, 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

2d701c64-bffb-4ab3-a1f9-b47858ca50cb

Public Version Date

May 20, 2019

Public Version Number

5

DI Record Publish Date

August 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-