Darby Dental Supply, LLC - ETCH GEL 1ML - DARBY DENTAL SUPPLY, LLC

Duns Number:825137818

Device Description: ETCH GEL 1ML

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More Product Details

Catalog Number

9520878

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9520878

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K931880,K931880

Product Code Details

Product Code

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Device Record Status

Public Device Record Key

a7423d5c-e14c-4b06-a524-c2eaa5bbdadb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DARBY DENTAL SUPPLY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1457
2 A medical device with a moderate to high risk that requires special controls. 194
U Unclassified 2