Twist Drill D=3.80mm,L=5.5mm - Twist Drill D=3.80mm,L=5.5mm - DENTACK IMPLANTS LTD

Duns Number:514897185

Device Description: Twist Drill D=3.80mm,L=5.5mm

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More Product Details

Catalog Number

-

Brand Name

Twist Drill D=3.80mm,L=5.5mm

Version/Model Number

TSD-385

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

c06ed0e4-2e1c-4c69-adeb-cc606b671383

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

March 02, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTACK IMPLANTS LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 45
2 A medical device with a moderate to high risk that requires special controls. 70