Cleared Traditional

K070869 - PROPHY STAR 3 HYGIENE HANDPIECE

K070869 is the FDA 510(k) clearance for PROPHY STAR 3 HYGIENE HANDPIECE by Dentalez, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K070869 · Dentalez, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
78d
Days
Class 1
Risk

K070869 is an FDA 510(k) clearance for the PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dentalez, Inc. (Lancaster, US). The FDA issued a Cleared decision on June 15, 2007 after a review of 78 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, Inc. devices

Submission Details

510(k) Number K070869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2007
Decision Date June 15, 2007
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 67
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K070869.
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
K082827 · A-Dec, Inc. · Jan 2009
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
K073478 · Sybron Dental Specialties, Inc. · Sep 2008
A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
K070663 · A-Dec, Inc. · Jul 2007
LUBRINA, MODEL HIM-1
K070074 · J. Morita USA, Inc. · May 2007
AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV
K043497 · J. Morita USA, Inc. · Mar 2005
TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE
K043498 · J. Morita USA, Inc. · Feb 2005