Cleared Traditional

K840237 - MAX-I-PROBE PERIODONTAL ENDODONTIC PROB

K840237 is an FDA 510(k) clearance for MAX-I-PROBE PERIODONTAL ENDODONTIC PROB, manufactured by Smith & Nephew, Mpl Division. The device is a Class 1 Dental device with product code EIC cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K840237 · Smith & Nephew, Mpl Division · Dental device
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Apr 1984
Decision
76d
Days
Class 1
Risk

K840237 is an FDA 510(k) clearance for the MAX-I-PROBE PERIODONTAL ENDODONTIC PROB. Classified as Syringe, Periodontic, Endodontic, Irrigating (product code EIC), Class I - General Controls.

Submitted by Smith & Nephew, Mpl Division (Walker, US). The FDA issued a Cleared decision on April 5, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Smith & Nephew, Mpl Division devices

FDA 510(k) Submission Details - K840237

510(k) Number K840237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1984
Decision Date April 05, 1984
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

EIC Device Classification - Class 1, General Controls

Product Code EIC Syringe, Periodontic, Endodontic, Irrigating
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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 - EIC Syringe, Periodontic, Endodontic, Irrigating

All 7
Devices cleared under the same product code (EIC) and FDA review panel - the closest regulatory comparables to K840237.
RCT GEL ROOT CANAL THERAPY GEL
K972234 · Dentsply Intl. · Jun 1997
MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)
K864307 · Smith & Nephew, Inc. · Nov 1986
MARK IV SYRINGE
K801483 · National Patent Development Corp. · Jul 1980
ROOT CANAL FILLING APPLICATOR NEEDLES
K801484 · National Patent Development Corp. · Jul 1980
CENTRIX MKIV ENDODONTIC DELIVERY
K792461 · Centrix, Inc. · Dec 1979
SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE
K770967 · National Patent Development Corp. · Jun 1977