SIS(Luna) - Dental Implant System is intended to be - Shinhung MST Co., Ltd.

Duns Number:689667152

Device Description: Dental Implant System is intended to be surgically placed in the bone of the upper or lowe Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing fuction.

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More Product Details

Catalog Number

-

Brand Name

SIS(Luna)

Version/Model Number

NSIR6008SF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K160106,K160106

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

41e48062-11a2-4bcd-95a6-34b0ccc7c6fa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 10, 2016

Additional Identifiers

Package DI Number

18809457201898

Quantity per Package

20

Contains DI Package

08809457201891

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SHINHUNG MST CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 542
2 A medical device with a moderate to high risk that requires special controls. 133