Cleared Traditional

K961158 - SUPRASSON P5 BOOSTER

K961158 is an FDA 510(k) clearance for SUPRASSON P5 BOOSTER, manufactured by Satelec. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K961158 · Satelec · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
62d
Days
Class 2
Risk

K961158 is an FDA 510(k) clearance for the SUPRASSON P5 BOOSTER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Satelec (Wellesley, US). The FDA issued a Cleared decision on May 23, 1996 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 Satelec devices

FDA 510(k) Submission Details - K961158

510(k) Number K961158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1996
Decision Date May 23, 1996
Days to Decision 62 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
65d faster than avg
Panel avg: 127d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 74
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K961158.
SP4044 & SP4055 LUX MODULES
K972026 · Satelec · Jul 1997
DENTSPLY CAVITRON SPS SCALER SYSTEM
K970123 · Dentsply Intl. · Apr 1997
CAVITRON JET WITH SPS SYSTEM
K970342 · Dentsply Intl. · Apr 1997
SUPRASSON P MAX
K942139 · Satelec · Sep 1995
LE CLEAN MACHINE
K950240 · Parkell, Inc. · Apr 1995
TURBO 25/30
K950256 · Parkell, Inc. · Apr 1995