EXCEL HIGH SPEED DENTAL HANDPIECE

Handpiece, Belt And/or Gear Driven, Dental

ORTHOSOURCE, INC.

The following data is part of a premarket notification filed by Orthosource, Inc. with the FDA for Excel High Speed Dental Handpiece.

Pre-market Notification Details

Device IDK061581
510k NumberK061581
Device Name:EXCEL HIGH SPEED DENTAL HANDPIECE
ClassificationHandpiece, Belt And/or Gear Driven, Dental
Applicant ORTHOSOURCE, INC. 13343 SHERMAN WAY North Hollywood,  CA  91605
ContactLloyd Taylor
CorrespondentLloyd Taylor
ORTHOSOURCE, INC. 13343 SHERMAN WAY North Hollywood,  CA  91605
Product CodeEFA  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-07
Decision Date2006-08-16

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