Cleared Traditional

Maxima Electric System (K180845) - FDA 510(k) Clearance

Class I Dental device.

K180845 · Handpiece Headquarters - Hpr, Inc. · Dental device
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Jul 2019
Decision
479d
Days
Class 1
Risk

K180845 is an FDA 510(k) clearance for the Maxima Electric System. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Handpiece Headquarters - Hpr, Inc. (Placentia, US). The FDA issued a Cleared decision on July 25, 2019 after a review of 479 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 Handpiece Headquarters - Hpr, Inc. devices

Submission Details

510(k) Number K180845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2018
Decision Date July 25, 2019
Days to Decision 479 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
352d slower than avg
Panel avg: 127d · This submission: 479d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBW Controller, Foot, Handpiece And Cord
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 - EBW Controller, Foot, Handpiece And Cord

All 60
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K180845.
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