i-Clean straight Fixture - Dental Implant System / i-Clean straight Fixture - DENTIS CO. ,LTD

Duns Number:694721181

Device Description: Dental Implant System / i-Clean straight Fixture D4.75mm X L10.0mm

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More Product Details

Catalog Number

-

Brand Name

i-Clean straight Fixture

Version/Model Number

DISF4810S

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

K171027

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

42f55974-8988-4fe7-b45b-24675584a5b2

Public Version Date

May 26, 2021

Public Version Number

3

DI Record Publish Date

June 18, 2019

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