Cleared Traditional

PROBE TIP/PERI PROBE/PERI PROBE COMP. (K936221) - FDA 510(k) Clearance

Class I Dental device.

K936221 · Pd International AB · Dental device
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Aug 1994
Decision
217d
Days
Class 1
Risk

K936221 is an FDA 510(k) clearance for the PROBE TIP/PERI PROBE/PERI PROBE COMP.. Classified as Probe, Periodontic (product code EIX), Class I - General Controls.

Submitted by Pd International AB (Sloane, SE). The FDA issued a Cleared decision on August 1, 1994 after a review of 217 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Pd International AB devices

Submission Details

510(k) Number K936221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1993
Decision Date August 01, 1994
Days to Decision 217 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
90d slower than avg
Panel avg: 127d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIX Probe, Periodontic
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.