Infinix Bulk Fill Flow Composite - Dental Composite - TranslucentSingle dose - NOBIO LTD

Duns Number:532282466

Device Description: Dental Composite - TranslucentSingle dose

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More Product Details

Catalog Number

-

Brand Name

Infinix Bulk Fill Flow Composite

Version/Model Number

INF-BF-FP-SD-TR

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

K201010,K201010

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

24cdc3eb-fefb-4080-90e6-2f9a62f5b52a

Public Version Date

March 23, 2021

Public Version Number

1

DI Record Publish Date

March 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOBIO LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 28