K3Pro Konus Dental Implants - RapidFix/ Bar Base Abut Cap - HSL - Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG

Duns Number:312649568

Device Description: RapidFix/ Bar Base Abut Cap - HSL

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

VBA50000PKK.HSLA

Brand Name

K3Pro Konus Dental Implants

Version/Model Number

VBA50000PKK.HSLA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K141159

Product Code Details

Product Code

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

8025a3ad-1b6b-41d3-8dfe-8d5b5b087044

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARGON MEDICAL PRODUCTIONS & VERTRIEBS GESELLSCHAFT MBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 65
2 A medical device with a moderate to high risk that requires special controls. 267