FDA · official record K161989Substantially Equivalent

PREMIUM Implant Systems SHELTA Implant Systems

Name: PREMIUM Implant Systems SHELTA Implant Systems — FDA K161989
Creator: Sweden & Martina S.P.A.
Keywords: PREMIUM Implant Systems SHELTA Implant Systems, PREMIUM Implant Systems SHELTA Implant Systems, K161989, NHA, FDA

United StatesNHASweden & Martina S.P.A.

Verified

Official record identity

FDA application number: K161989
Decision date: February 01, 2018
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Sweden & Martina S.P.A.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2016-07-19
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.