Cleared Traditional

DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125

K041141 · Dentsply Intl. · Dental
Jun 2004
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K041141 is an FDA 510(k) clearance for the DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on June 16, 2004, 47 days after receiving the submission on April 30, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K041141 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2004
Decision Date June 16, 2004
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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