ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE

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 1:1 Contra Angle, Athena 4:1 Contra Angle, Athena 16:1 Contra Angle, Athena 64:1 Contra Angle, Athena 16-: Contre.

Pre-market Notification Details

Device IDK974670
510k NumberK974670
Device Name:ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE
ClassificationHandpiece, Air-powered, Dental
Applicant ATHENA TECHNOLOGY, INC. 984 NORTH AMELIA AVE. San Dimas,  CA  91773
ContactWlliam T Anderson
CorrespondentWlliam T Anderson
ATHENA TECHNOLOGY, INC. 984 NORTH AMELIA AVE. San Dimas,  CA  91773
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-15
Decision Date1998-03-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10302730001959 K974670 000
10302730001935 K974670 000
10302730001904 K974670 000
10302730001881 K974670 000
10302730001874 K974670 000
10302730001867 K974670 000
10302730001850 K974670 000

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