EsFlow A2 Syringe - Nano-hybrid Flowable composite resin for - Spident Co., Ltd.

Duns Number:689370711

Device Description: Nano-hybrid Flowable composite resin for posterior and anterior restorations.

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More Product Details

Catalog Number

101-0802

Brand Name

EsFlow A2 Syringe

Version/Model Number

101-0802

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)

-

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

b6595ff7-da51-4931-b0ec-97f549a1d23f

Public Version Date

January 26, 2021

Public Version Number

7

DI Record Publish Date

February 20, 2017

Additional Identifiers

Package DI Number

20210305170597

Quantity per Package

420

Contains DI Package

08809262954722

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

-

"SPIDENT CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6