TatumSurgical/Screw Implant - Screw Dental Implant 6.0mm in diameter and 14mm - Suncoast Dental, Inc

Duns Number:078352849

Device Description: Screw Dental Implant 6.0mm in diameter and 14mm in length

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More Product Details

Catalog Number

IS 6.0 x 14mm

Brand Name

TatumSurgical/Screw Implant

Version/Model Number

Screw/6.0 x 14

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

K811923

Product Code Details

Product Code

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Device Record Status

Public Device Record Key

73ef63be-ee24-4e81-8871-a4bfdb86aaa7

Public Version Date

August 27, 2021

Public Version Number

4

DI Record Publish Date

October 30, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNCOAST DENTAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 405
2 A medical device with a moderate to high risk that requires special controls. 536