Quantum - Q Fit Abutment 5.0-25° 3S - QUANTUM BIOENGINEERING LTD.

Duns Number:797604456

Device Description: Q Fit Abutment 5.0-25° 3S

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More Product Details

Catalog Number

512-060-025-3

Brand Name

Quantum

Version/Model Number

512-060-025-3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K112279

Product Code Details

Product Code

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Record Status

Public Device Record Key

20427666-af8f-424b-9263-321992e12f83

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

April 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QUANTUM BIOENGINEERING LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 269