TatumSurgical/Abutment (Post) - Implant Abutment 6.0mm x 10 degree -5mm Height - Suncoast Dental, Inc

Duns Number:078352849

Device Description: Implant Abutment 6.0mm x 10 degree -5mm Height

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More Product Details

Catalog Number

PN60.10S

Brand Name

TatumSurgical/Abutment (Post)

Version/Model Number

Abutment/6.0mm x 10 degree Post - Short

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

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

35deb462-9d41-4a5b-a47e-164cf64a5114

Public Version Date

June 18, 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