FDA · official record K092248Substantially Equivalent

SPI CUSTOMIZABLE GINGIVA FORMER

Name: SPI CUSTOMIZABLE GINGIVA FORMER — FDA K092248
Creator: Thommen Medical AG
Keywords: SPI CUSTOMIZABLE GINGIVA FORMER, SPI CUSTOMIZABLE GINGIVA FORMER, K092248, NHA, FDA

United StatesNHAThommen Medical AG

Verified

Official record identity

FDA application number: K092248
Decision date: September 25, 2009
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Thommen Medical AG

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2009-07-28
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.