Catalog Number

619500

Brand Name

Regisil® 2X™ Vinyl Polysiloxane Bite Registration Paste

Version/Model Number

619500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code

EID

Product Code Name

SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Public Device Record Key

d809cbd4-4e96-4931-a747-00e4476a8a2f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

D00261950082

Quantity per Package

8

Contains DI Package

D0026195001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box