Cleared Traditional

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

K072213 · Perimetrics, Inc. · Dental device

Aug 2008

Decision

386d

Days

Class 1

Risk

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

Submitted by Perimetrics, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on August 29, 2008, 386 days after receiving the submission on August 9, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.

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