FDA · official record K062812Substantially Equivalent

DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N

Name: DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N — FDA K062812
Creator: Thunder Tiger Corp.
Keywords: DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N, DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N, K062812, EFB, FDA

United StatesEFBThunder Tiger Corp.

Verified

Official record identity

FDA application number: K062812
Decision date: November 28, 2006
Published decision: Substantially Equivalent

Classification

Product code: EFB

Published parties

Applicant: Thunder Tiger Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2006-09-19
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.