Cleared Traditional

K951272 - RELACS 7000

K951272 is an FDA 510(k) clearance for RELACS 7000, manufactured by Micro-Mega Societe Anonyme. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K951272 · Micro-Mega Societe Anonyme · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
52d
Days
Class 2
Risk

K951272 is an FDA 510(k) clearance for the RELACS 7000. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Micro-Mega Societe Anonyme (Besancon, FR). The FDA issued a Cleared decision on May 12, 1995 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 Micro-Mega Societe Anonyme devices

FDA 510(k) Submission Details - K951272

510(k) Number K951272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1995
Decision Date May 12, 1995
Days to Decision 52 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 127d · This submission: 52d
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 84
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K951272.
CAVITRON JET WITH SPS SYSTEM
K970342 · Dentsply Intl. · Apr 1997
SUPRASSON P5 BOOSTER
K961158 · Satelec · May 1996
SUPRASSON P MAX
K942139 · Satelec · Sep 1995
LE CLEAN MACHINE
K950240 · Parkell, Inc. · Apr 1995
TURBO 25/30
K950256 · Parkell, Inc. · Apr 1995
JET UNIT (CJ HANDPIECE)
K941392 · Dentsply Intl. · May 1994