Ezfil D2 - Dental composite resin is a device intended to - Meta Biomed Co., Ltd.

Duns Number:688322841

Device Description: Dental composite resin is a device intended to restore carious lesions or structural defec Dental composite resin is a device intended to restore carious lesions or structural defects in teeth.Ezfil is indicated for Class 1, 2, 3, 4, 5 restorations, Core-buildup to replace missing tooth structure, Diastema closures, Direct veneers, Composite and porcelain repairs.The color is 18 colors with A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, OP and TL.

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More Product Details

Catalog Number

-

Brand Name

Ezfil D2

Version/Model Number

9429

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

K191991

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

b20616d0-0d33-4e6b-8f45-0907b2410dc9

Public Version Date

March 23, 2020

Public Version Number

1

DI Record Publish Date

March 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"META BIOMED CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1335
2 A medical device with a moderate to high risk that requires special controls. 284