Cleared Traditional

INTRA LUX HEAD 3 LDSY

K092446 · Kaltenbach & Voigt GmbH & Co. · Dental

Nov 2009

Decision

85d

Days

Class 1

Risk

About This 510(k) Submission

K092446 is an FDA 510(k) clearance for the INTRA LUX HEAD 3 LDSY, a Handpiece, Belt And/or Gear Driven, Dental (Class I — General Controls, product code EFA), submitted by Kaltenbach & Voigt GmbH & Co. (Orange, US). The FDA issued a Cleared decision on November 3, 2009, 85 days after receiving the submission on August 10, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K092446 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 10, 2009
Decision Date	November 03, 2009
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF