Cleared Traditional

K974670 - ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE

K974670 is an FDA 510(k) clearance for ATHENA 1:1 CONTRA ANGLE, manufactured by Athena Technology, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K974670 · Athena Technology, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
88d
Days
Class 1
Risk

K974670 is an FDA 510(k) clearance for the ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, A.... Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Athena Technology, Inc. (San Dimas, US). The FDA issued a Cleared decision on March 13, 1998 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Athena Technology, Inc. devices

FDA 510(k) Submission Details - K974670

510(k) Number K974670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1997
Decision Date March 13, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 113
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K974670.
PRO-FLEX DISPOSABLE PROPHY ANGLE
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MACH-SIGMA HANDPIECE, ULTRAPUSH
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ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR
K974671 · Athena Technology, Inc. · Mar 1998
PROPHYFLEX 2, MODEL 2012
K973876 · Kavo America · Dec 1997
T1 LINE DENTAL HANDPIECES
K972436 · Siemens AG · Sep 1997