EXCEL CONTRA ANGLE HANDPIECE

Handpiece, Contra- And Right-angle Attachment, Dental

ORTHOSOURCE, INC.

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

Pre-market Notification Details

Device IDK061897
510k NumberK061897
Device Name:EXCEL CONTRA ANGLE HANDPIECE
ClassificationHandpiece, Contra- And Right-angle Attachment, 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 CodeEGS  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-03
Decision Date2007-02-14

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