Cleared Traditional

K905155 - HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES (FDA 510(k) Clearance)

Class I Dental device.

K905155 · Star Dental Mfg. Co. · Dental device
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Feb 1991
Decision
90d
Days
Class 1
Risk

K905155 is an FDA 510(k) clearance for the HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Star Dental Mfg. Co. (Lancaster, US). The FDA issued a Cleared decision on February 13, 1991 after a review of 90 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 Star Dental Mfg. Co. devices

Submission Details

510(k) Number K905155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1990
Decision Date February 13, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 260
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