HySil Impression Materials - Osstem Implant Co.,Ltd.

Duns Number:694893867

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More Product Details

Catalog Number

-

Brand Name

HySil Impression Materials

Version/Model Number

ESS400P

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

K170736

Product Code Details

Product Code

ELW

Product Code Name

Material, Impression

Device Record Status

Public Device Record Key

cc60e501-9263-45e4-b056-cb5ea597f677

Public Version Date

November 25, 2020

Public Version Number

1

DI Record Publish Date

November 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSSTEM IMPLANT 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. 34