Cleared Traditional

K872171 - PERIOTEST (FDA 510(k) Clearance)

Jun 1987
Decision
15d
Days
Class 1
Risk

K872171 is an FDA 510(k) clearance for the PERIOTEST. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on June 23, 1987, 15 days after receiving the submission on June 8, 1987.

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

Submission Details

510(k) Number K872171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date June 23, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.4200