Cleared Traditional

LOW & HIGH SPEED KIT

K090055 · Dpm USA Corp. · Dental

Oct 2009

Decision

292d

Days

Class 1

Risk

About This 510(k) Submission

K090055 is an FDA 510(k) clearance for the LOW & HIGH SPEED KIT, a Handpiece, Belt And/or Gear Driven, Dental (Class I — General Controls, product code EFA), submitted by Dpm USA Corp. (Miami, US). The FDA issued a Cleared decision on October 27, 2009, 292 days after receiving the submission on January 8, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K090055 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 08, 2009
Decision Date	October 27, 2009
Days to Decision	292 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF