Cleared Traditional

RDT3 HANDPIECE HEAD MODEL RDT3

K101172 · Redent-Nova , Ltd. · Dental

Jul 2010

Decision

92d

Days

Class 1

Risk

About This 510(k) Submission

K101172 is an FDA 510(k) clearance for the RDT3 HANDPIECE HEAD MODEL RDT3, a Handpiece, Belt And/or Gear Driven, Dental (Class I — General Controls, product code EFA), submitted by Redent-Nova , Ltd. (Washington, US). The FDA issued a Cleared decision on July 27, 2010, 92 days after receiving the submission on April 26, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K101172 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2010
Decision Date	July 27, 2010
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF