Advance Dental Products - ADVANCE FLOWABLE COMPOSITE B1 1.8G SYRINGE - The Atlanta Dental Supply Company

Duns Number:033505389

Device Description: ADVANCE FLOWABLE COMPOSITE B1 1.8G SYRINGE

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

825260B1

Brand Name

Advance Dental Products

Version/Model Number

825260B1

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

Yes

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 Details

Product Code

EBC

Product Code Name

SEALANT, PIT AND FISSURE, AND CONDITIONER

Device Record Status

Public Device Record Key

4a5533dd-9f04-4763-a7ff-75a92065655d

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THE ATLANTA DENTAL SUPPLY COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 18