FDA · official record K990545Substantially Equivalent

JETSONIC 2000

Name: JETSONIC 2000 — FDA K990545
Creator: Sds Dental, Inc.
Keywords: JETSONIC 2000, JETSONIC 2000, K990545, KOJ, FDA

United StatesKOJSds Dental, Inc.

Verified

Official record identity

FDA application number: K990545
Decision date: August 11, 1999
Published decision: Substantially Equivalent

Classification

Product code: KOJ

Published parties

Applicant: Sds Dental, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1999-02-22
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6080

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.