Cleared Traditional

K072213 - PERIMETRICS PERIOMETER (FDA 510(k) Clearance)

Class I Dental device.

K072213 · Perimetrics, Inc. · Dental device
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Aug 2008
Decision
386d
Days
Class 1
Risk

K072213 is an FDA 510(k) clearance for the PERIMETRICS PERIOMETER. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Perimetrics, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on August 29, 2008 after a review of 386 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: 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 Perimetrics, Inc. devices

Submission Details

510(k) Number K072213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2007
Decision Date August 29, 2008
Days to Decision 386 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
259d slower than avg
Panel avg: 127d · This submission: 386d
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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