FDA · official record K062947Substantially Equivalent

HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES

Name: HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES — FDA K062947
Creator: Peng Lim Enterprise Co., Ltd.
Keywords: HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES, HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES, K062947, EFB, FDA

United StatesEFBPeng Lim Enterprise Co., Ltd.

Verified

Official record identity

FDA application number: K062947
Decision date: December 14, 2006
Published decision: Substantially Equivalent

Classification

Product code: EFB

Published parties

Applicant: Peng Lim Enterprise Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2006-09-28
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4200

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.