Cleared Traditional

K072989 - AXIS SYSTEM

K072989 is an FDA 510(k) clearance for AXIS SYSTEM, manufactured by Dentsply Intl., Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K072989 · Dentsply Intl., Inc. · Dental device
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Jan 2008
Decision
97d
Days
Class 1
Risk

K072989 is an FDA 510(k) clearance for the AXIS SYSTEM. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dentsply Intl., Inc. (York, US). The FDA issued a Cleared decision on January 28, 2008 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Intl., Inc. devices

FDA 510(k) Submission Details - K072989

510(k) Number K072989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2007
Decision Date January 28, 2008
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 127d · This submission: 97d
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 186
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