Cleared Traditional

K943841 - SOPHOS DENTAL DIAMOND

K943841 is an FDA 510(k) clearance for SOPHOS DENTAL DIAMOND, manufactured by Sophos Technologic. The device is a Class 1 Dental device with product code DZP cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K943841 · Sophos Technologic · Dental device
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Sep 1994
Decision
42d
Days
Class 1
Risk

K943841 is an FDA 510(k) clearance for the SOPHOS DENTAL DIAMOND. Classified as Instrument, Diamond, Dental (product code DZP), Class I - General Controls.

Submitted by Sophos Technologic (San Clemente, US). The FDA issued a Cleared decision on September 16, 1994 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4535 - 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 Sophos Technologic devices

FDA 510(k) Submission Details - K943841

510(k) Number K943841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1994
Decision Date September 16, 1994
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

DZP Device Classification - Class 1, General Controls

Product Code DZP Instrument, Diamond, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4535
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 - DZP Instrument, Diamond, Dental

Devices cleared under the same product code (DZP) and FDA review panel - the closest regulatory comparables to K943841.
BLUWHITE DIAMOND DENTAL BURS MODIFIED
K120037 · Beavers Dental, Div. Sybron Canada, Ltd. · Apr 2012
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K901967 · Micro-Aire Surgical Instruments, Inc. · Jul 1990
HYBRID POINTS
K854347 · Shofu Dental Corp. · Dec 1985
GINGI CURETTAGE DIAMOND POINTS
K832856 · Shofu Dental Corp. · Oct 1983
SUMMA DISK
K833038 · Shofu Dental Corp. · Oct 1983
TPE DIAMOND POINTS
K832855 · Shofu Dental Corp. · Sep 1983