Cleared Traditional

K171872 - P50 Series Dental Operative Unit and Ac...

K171872 is the FDA 510(k) clearance for P50 Series Dental Operative Unit and Ac... by Pelton & Crane. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K171872 · Pelton & Crane · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
307d
Days
Class 1
Risk

K171872 is an FDA 510(k) clearance for the P50 Series Dental Operative Unit and Accessories. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Pelton & Crane (Charlotte, US). The FDA issued a Cleared decision on April 26, 2018 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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. Elevated predicate reliance profile. 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 Pelton & Crane devices

Submission Details

510(k) Number K171872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2017
Decision Date April 26, 2018
Days to Decision 307 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
180d slower than avg
Panel avg: 127d · This submission: 307d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

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