Cleared Traditional

K915634 - FRESENIUS PD+ EXCHANGE DEVICE (FDA 510(k) Clearance)

Class I Dental device.

K915634 · Fresenius USA, Inc. · Dental device
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Jul 1993
Decision
562d
Days
Class 1
Risk

K915634 is an FDA 510(k) clearance for the FRESENIUS PD+ EXCHANGE DEVICE. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on July 1, 1993 after a review of 562 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Fresenius USA, Inc. devices

Submission Details

510(k) Number K915634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1991
Decision Date July 01, 1993
Days to Decision 562 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
435d slower than avg
Panel avg: 127d · This submission: 562d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EKX Handpiece, Direct Drive, Ac-powered

All 88
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