Surgical Kit - These Drills are surgical tools that are used to - Shinhung MST Co., Ltd.

Duns Number:689667152

Device Description: These Drills are surgical tools that are used to expect the direction and place of implant These Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.

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More Product Details

Catalog Number

-

Brand Name

Surgical Kit

Version/Model Number

LSD5013

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)

Yes

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

DZA

Product Code Name

Drill, Dental, Intraoral

Device Record Status

Public Device Record Key

17c23fa5-3949-47d0-b481-277899ce8bec

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

July 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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