s-Clean Multi Use Coping Driver - Dental Implant Instrument / s-Clean Multi Use - DENTIS CO. ,LTD

Duns Number:694721181

Device Description: Dental Implant Instrument / s-Clean Multi Use Coping Driver

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More Product Details

Catalog Number

-

Brand Name

s-Clean Multi Use Coping Driver

Version/Model Number

DHIHL

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

2c608636-79b3-46d8-8135-a78bf7d5d36b

Public Version Date

December 06, 2021

Public Version Number

1

DI Record Publish Date

November 26, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTIS CO. ,LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1118
2 A medical device with a moderate to high risk that requires special controls. 4011