FDA · official record K201561Substantially Equivalent

Membrane Screws and Membrane Tacks

Name: Membrane Screws and Membrane Tacks — FDA K201561
Creator: Neoss Limited
Keywords: Membrane Screws and Membrane Tacks, Membrane Screws and Membrane Tacks, K201561, DZL, FDA

United StatesDZLNeoss Limited

Verified

Official record identity

FDA application number: K201561
Decision date: October 05, 2020
Published decision: Substantially Equivalent

Classification

Product code: DZL

Published parties

Applicant: Neoss Limited

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2020-06-10
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4880

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.