FDA · official record K992582Substantially Equivalent

PACIFIC IMPLANT TITANIUM ENDODONTIC POINT

Name: PACIFIC IMPLANT TITANIUM ENDODONTIC POINT — FDA K992582
Creator: Pacific Implant, Inc.
Keywords: PACIFIC IMPLANT TITANIUM ENDODONTIC POINT, PACIFIC IMPLANT TITANIUM ENDODONTIC POINT, K992582, EKL, FDA

United StatesEKLPacific Implant, Inc.

Verified

Official record identity

FDA application number: K992582
Decision date: October 21, 1999
Published decision: Substantially Equivalent

Classification

Product code: EKL

Published parties

Applicant: Pacific Implant, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1999-08-02
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.3840

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.