Catalog Number

651020

Brand Name

Caulk® Orthodontic Resin

Version/Model Number

651020

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2021

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

-

Product Code

EBI

Product Code Name

RESIN, DENTURE, RELINING, REPAIRING, REBASING

Public Device Record Key

807582b6-afcf-428d-b587-62e2e9f15d9c

Public Version Date

October 03, 2022

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-