FDA · official record K191191Substantially Equivalent

Neodent Implant System - Temporary Abutments

Name: Neodent Implant System - Temporary Abutments — FDA K191191
Creator: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Keywords: Neodent Implant System - Temporary Abutments, Neodent Implant System - Temporary Abutments, K191191, NHA, FDA

United StatesNHAJjgc Industria E Comercio DE Materiais Dentarios S.A.

Verified

Official record identity

FDA application number: K191191
Decision date: December 05, 2019
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2019-05-03
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.