INTERFACE - DENTAL CAVITY LINER DENTIN SHADE - TEMREX CORPORATION

Duns Number:012072823

Device Description: DENTAL CAVITY LINER DENTIN SHADE

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More Product Details

Catalog Number

-

Brand Name

INTERFACE

Version/Model Number

7110

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K897130

Product Code Details

Product Code

EJK

Product Code Name

Liner, Cavity, Calcium Hydroxide

Device Record Status

Public Device Record Key

87b93f55-693c-462f-98de-1bcfa9811c8b

Public Version Date

February 20, 2020

Public Version Number

1

DI Record Publish Date

February 12, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEMREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 40