GUTTA PERCHA POINT 4% - N°50 - Gutta percha point is used to fill a prepared - Produits dentaires S.A.

Duns Number:480420090

Device Description: Gutta percha point is used to fill a prepared root canal prior to tooth restoration. It is Gutta percha point is used to fill a prepared root canal prior to tooth restoration. It is used to fill the endodontic cavity to result in complete sealing in order to prevent reoccurrence of pathologies in root canal which may occur if root canal is not obturated.Box of 60 pieces - Length 28mm - Color Code: Yellow

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More Product Details

Catalog Number

-

Brand Name

GUTTA PERCHA POINT 4% - N°50

Version/Model Number

24032

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)

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

EKM

Product Code Name

Gutta-Percha

Device Record Status

Public Device Record Key

2d4574b8-c6ed-4714-b175-7ef18b0c30e6

Public Version Date

June 30, 2022

Public Version Number

1

DI Record Publish Date

June 22, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRODUITS DENTAIRES S.A." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 278
2 A medical device with a moderate to high risk that requires special controls. 1