Cleared Traditional

PLS-96P (K973088) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973088 · Southern Dental Industries, Inc. · Dental device
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Oct 1997
Decision
46d
Days
Class 2
Risk

K973088 is an FDA 510(k) clearance for the PLS-96P. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Southern Dental Industries, Inc. (San Francisco, US). The FDA issued a Cleared decision on October 3, 1997 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 Southern Dental Industries, Inc. devices

Submission Details

510(k) Number K973088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1997
Decision Date October 03, 1997
Days to Decision 46 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
81d faster than avg
Panel avg: 127d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
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 - EJJ Alloy, Amalgam

All 73
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K973088.
CENTURY ALLOY
K974035 · Dentsply Intl. · Dec 1997
VALULINE* AMALGAM ALLOY
K821971 · Johnson & Johnson Professionals, Inc. · Jul 1982
A DENTAL AMALGAM ALLOY (UNNAMED
K820389 · Dentsply Intl. · Mar 1982
ORBIC* SPHERICAL ALLOY
K812827 · Johnson & Johnson Professionals, Inc. · Nov 1981
ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP
K771383 · Johnson & Johnson Professionals, Inc. · Aug 1977