PLUGGERS - Pluggers are used for vertical condensation of - DiaDent Group International

Duns Number:687789453

Device Description: Pluggers are used for vertical condensation of root canal fillings.

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More Product Details

Catalog Number

521-201

Brand Name

PLUGGERS

Version/Model Number

25m/m 8

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)

Yes

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

EKK

Product Code Name

Spreader, Pulp Canal Filling Material, Endodontic

Device Record Status

Public Device Record Key

7b9a6e37-8f12-4466-b9f9-856340c7a6aa

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

June 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIADENT GROUP INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4806
2 A medical device with a moderate to high risk that requires special controls. 158