FDA · official record K864474Substantially Equivalent

DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC

Name: DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC — FDA K864474
Creator: Planmeca USA, Inc.
Keywords: DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC, DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC, K864474, EHD, FDA

United StatesEHDPlanmeca USA, Inc.

Verified

Official record identity

FDA application number: K864474
Decision date: November 26, 1986
Published decision: Substantially Equivalent

Classification

Product code: EHD

Published parties

Applicant: Planmeca USA, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1986-11-13
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1800

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.