FDA · official record K051050Substantially Equivalent

SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092

Name: SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 — FDA K051050
Creator: Schutz-Dental GmbH
Keywords: SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092, SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092, K051050, KLE, FDA

United StatesKLESchutz-Dental GmbH

Verified

Official record identity

FDA application number: K051050
Decision date: June 29, 2005
Published decision: Substantially Equivalent

Classification

Product code: KLE

Published parties

Applicant: Schutz-Dental GmbH

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2005-04-25
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3200

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.