Cleared Traditional

POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185

K032607 · Linvatec Corp. · Dental
Nov 2003
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K032607 is an FDA 510(k) clearance for the POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185, a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on November 10, 2003, 77 days after receiving the submission on August 25, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K032607 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2003
Decision Date November 10, 2003
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZI — Drill, Bone, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120