Cleared Traditional

K864307 - MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)

K864307 is an FDA 510(k) clearance for MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE..., manufactured by Smith & Nephew, Inc.. The device is a Class 1 Dental device with product code EIC cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K864307 · Smith & Nephew, Inc. · Dental device
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Nov 1986
Decision
15d
Days
Class 1
Risk

K864307 is an FDA 510(k) clearance for the MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI). Classified as Syringe, Periodontic, Endodontic, Irrigating (product code EIC), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Chicago, US). The FDA issued a Cleared decision on November 18, 1986 after a review of 15 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.

FDA 510(k) Submission Details - K864307

510(k) Number K864307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1986
Decision Date November 18, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 128d · This submission: 15d
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 15
Devices cleared under the same product code (EIC) and FDA review panel - the closest regulatory comparables to K864307.
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HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT
K861846 · Solar Dental Co., Inc. · Jun 1986
MAX-I-PROBE HANDPIECE
K851944 · Solo Pak Laboratories · Jul 1985
MAX-I-PROBE PERIODONTAL ENDODONTIC PROB
K840237 · Smith & Nephew, Mpl Division · Apr 1984
R & S SERIES FITTING TOOLS
K811889 · Suncoast Dental Corp. · Jul 1981
WATER PISTOL
K811594 · Aus-Tex Dental Mfg. & Design · Jul 1981
K864307 · MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)
Download PDF Smith & Nephew, Inc.