Cleared Special

K060270 - MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
(FDA 510(k) Clearance)

K060270 · Linvatec Corp. · Dental device

Apr 2006

Decision

68d

Days

Class 2

Risk

K060270 is an FDA 510(k) clearance for the MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL. This device is classified as a Drill, Bone, Powered (Class II - Special Controls, product code DZI).

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on April 10, 2006, 68 days after receiving the submission on February 1, 2006.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number	K060270 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 01, 2006
Decision Date	April 10, 2006
Days to Decision	68 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF