Cleared Traditional

K960719 - STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE (FDA 510(k) Clearance)

Class I Dental device.

K960719 · Dentalez Group · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
36d
Days
Class 1
Risk

K960719 is an FDA 510(k) clearance for the STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE. Classified as Handpiece, Belt And/or Gear Driven, Dental (product code EFA), Class I - General Controls.

Submitted by Dentalez Group (Lancaster, US). The FDA issued a Cleared decision on March 28, 1996 after a review of 36 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 Dentalez Group devices

Submission Details

510(k) Number K960719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1996
Decision Date March 28, 1996
Days to Decision 36 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
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFA Handpiece, Belt And/or Gear Driven, 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.