Cleared Traditional

STRONG IMPLANT HANDPIECES

K092412 · Saeshin Precision Co., Ltd. · Dental
Sep 2009
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K092412 is an FDA 510(k) clearance for the STRONG IMPLANT HANDPIECES, a Handpiece, Belt And/or Gear Driven, Dental (Class I — General Controls, product code EFA), submitted by Saeshin Precision Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on September 3, 2009, 28 days after receiving the submission on August 6, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K092412 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2009
Decision Date September 03, 2009
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFA — Handpiece, Belt And/or Gear Driven, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200