Suppra Flow - Suppra Flow is a light-curing composite resin - Dentscare Ltda

Duns Number:898067533

Device Description: Suppra Flow is a light-curing composite resin used for the restoration of slightly invasiv Suppra Flow is a light-curing composite resin used for the restoration of slightly invasive preparations, pit and fissure sealant, base/lining underneath direct restorations, in tunnel-type preparations, radiopaque lining of cavities, repairs of enamel defects, restorations of primary teeth, repairs in composite resin, bonding of tooth fragments, class I, III and V restorations, non-carious cervical lesions.

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More Product Details

Catalog Number

4000055512

Brand Name

Suppra Flow

Version/Model Number

A3 2g

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

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

6d57a910-cd73-462d-941a-f19da960c58a

Public Version Date

October 11, 2021

Public Version Number

1

DI Record Publish Date

October 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTSCARE LTDA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 99