Cleared Traditional

K202674 - Medidenta High Speed Handpieces

K202674 is an FDA 510(k) clearance for Medidenta High Speed Handpieces, manufactured by Pac-Dent, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 818-day FDA review.

K202674 · Pac-Dent, Inc. · Dental device
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Dec 2022
Decision
818d
Days
Class 1
Risk

K202674 is an FDA 510(k) clearance for the Medidenta High Speed Handpieces. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on December 12, 2022 after a review of 818 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 Pac-Dent, Inc. devices

FDA 510(k) Submission Details - K202674

510(k) Number K202674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2020
Decision Date December 12, 2022
Days to Decision 818 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
691d slower than avg
Panel avg: 127d · This submission: 818d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
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 - EFB Handpiece, Air-powered, Dental

All 90
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K202674.
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