Cleared Traditional

K936221 - PROBE TIP/PERI PROBE/PERI PROBE COMP.

K936221 is an FDA 510(k) clearance for PROBE TIP/PERI PROBE/PERI PROBE COMP., manufactured by Pd International AB. The device is a Class 1 Dental device with product code EIX cleared through the Traditional 510(k) pathway after a 217-day FDA review.

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

FDA 510(k) Submission Details - K936221

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.

EIX Device Classification - Class 1, General Controls

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.