Cleared Traditional

K072213 - PERIMETRICS PERIOMETER

K072213 is an FDA 510(k) clearance for PERIMETRICS PERIOMETER, manufactured by Perimetrics, Inc.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 386-day FDA review.

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

FDA 510(k) Submission Details - K072213

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
258d slower than avg
Panel avg: 128d · This submission: 386d
Pathway characteristics
Predicate-based equivalence.

EKX Device Classification - Class 1, General Controls

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 81
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