MEDENTiKA - MedentiLOC abutment incl. Screw - MEDENTiKA GmbH

Duns Number:537555497

Device Description: MedentiLOC abutment incl. Screw

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More Product Details

Catalog Number

E 2700-1

Brand Name

MEDENTiKA

Version/Model Number

E 2700-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

-

Product Code Details

Product Code

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Record Status

Public Device Record Key

2d60d91e-8dc9-4f51-8657-00c9646dd4d2

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

March 20, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDENTIKA GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 839
2 A medical device with a moderate to high risk that requires special controls. 2035