FDA · official record K230218Substantially Equivalent

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)

Name: DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) — FDA K230218
Creator: Dental Direkt GmbH
Keywords: DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series), DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series), K230218, NHA, FDA

United StatesNHADental Direkt GmbH

Verified

Official record identity

FDA application number: K230218
Decision date: April 25, 2023
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Dental Direkt GmbH

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2023-01-26
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3630

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.