Cleared Traditional

K960507 - STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES

K960507 is an FDA 510(k) clearance for STAR DENTAL PUSHBUTTON AUTOCHUCK REPLAC..., manufactured by Dentalez Group. The device is a Class 1 Dental device with product code EFA cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K960507 · Dentalez Group · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
52d
Days
Class 1
Risk

K960507 is an FDA 510(k) clearance for the STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES. 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 52 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.

FDA 510(k) Submission Details - K960507

510(k) Number K960507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1996
Decision Date March 28, 1996
Days to Decision 52 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
76d faster than avg
Panel avg: 128d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

EFA Device Classification - Class 1, General Controls

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.

Regulatory Peers - EFA Handpiece, Belt And/or Gear Driven, Dental

All 22
Devices cleared under the same product code (EFA) and FDA review panel - the closest regulatory comparables to K960507.
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K960260 · Dentalez Group · Mar 1996
STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE
K960719 · Dentalez Group · Mar 1996
SPACELINE FEEL 21
K953865 · J. Morita USA, Inc. · Mar 1996
K960507 · STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES
Download PDF FDA Summary Dentalez Group