Catalog Number

9515140

Brand Name

Darby Dental Supply, LLC

Version/Model Number

G6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K973185

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

75bc0876-12c6-4929-8bc8-355e0feeb461

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

July 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-