AEU-26L ELCTRONIC ENDODONTIC SYSTEM

Handpiece, Direct Drive, Ac-powered

ASEPTICO, INC.

The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Aeu-26l Elctronic Endodontic System.

Pre-market Notification Details

Device IDK111078
510k NumberK111078
Device Name:AEU-26L ELCTRONIC ENDODONTIC SYSTEM
ClassificationHandpiece, Direct Drive, Ac-powered
Applicant ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville,  WA  98072
ContactGrant Ramaley
CorrespondentJeff D Rongero
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeEKX  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-04-18
Decision Date2011-06-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813110023452 K111078 000
00813110023414 K111078 000

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