FDA · official record K152959Substantially Equivalent

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes

Name: Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes — FDA K152959
Creator: Sybron Dental Specialties
Keywords: Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes, Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes, K152959, KIF, FDA

United StatesKIFSybron Dental Specialties

Verified

Official record identity

FDA application number: K152959
Decision date: April 14, 2016
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Sybron Dental Specialties

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2015-10-07
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3820

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.