FDA · official record K023580Substantially Equivalent

STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM

Name: STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM — FDA K023580
Creator: Sterngold
Keywords: STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM, STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM, K023580, DZE, FDA

United StatesDZESterngold

Verified

Official record identity

FDA application number: K023580
Decision date: January 17, 2003
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Sterngold

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2002-10-24
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

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.