Cleared Traditional

K864307 - MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE...

K864307 is the FDA 510(k) clearance for MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE... by Smith & Nephew, Inc.. It is a Class 1 Dental device (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.

View all Smith & Nephew, Inc. devices

Submission Details

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
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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