ATHENA HIGH SPEED HANDPIECE

Handpiece, Air-powered, Dental

ATHENA TECHNOLOGY, INC.

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

Pre-market Notification Details

Device IDK925678
510k NumberK925678
Device Name:ATHENA HIGH SPEED HANDPIECE
ClassificationHandpiece, Air-powered, Dental
Applicant ATHENA TECHNOLOGY, INC. 420 S. VERMONT AVE. Glendora,  CA  91740
ContactWilliam T Anderson
CorrespondentWilliam T Anderson
ATHENA TECHNOLOGY, INC. 420 S. VERMONT AVE. Glendora,  CA  91740
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-10
Decision Date1994-12-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10302730001997 K925678 000
10302730001980 K925678 000
10302730001942 K925678 000
10302730000457 K925678 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.