Cleared Traditional

OsteoMed PINNACLE Driver

K162544 · Osteomed · Dental
Apr 2017
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K162544 is an FDA 510(k) clearance for the OsteoMed PINNACLE Driver, a Handpiece, Rotary Bone Cutting (Class II — Special Controls, product code KMW), submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on April 4, 2017, 204 days after receiving the submission on September 12, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K162544 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2016
Decision Date April 04, 2017
Days to Decision 204 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KMW — Handpiece, Rotary Bone Cutting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120

Similar Devices — KMW Handpiece, Rotary Bone Cutting

All 8
Oral Surgery Contra
K211584 · Nakanishi, Inc. · Aug 2021
Surgical Angle Handpiece, Surgical Straight Handpiece
K171155 · Nakanishi, Inc. · Nov 2017
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
K080939 · W&H Dentalwerk Buermoos GmbH · Jul 2008
FRIOS MICROSAW
K994298 · Friadent GmbH · Feb 2000
OSTEOPOWER SYSTEM AND ACCESSORIES
K971692 · Osteomed Corp. · Jun 1997
E-TYPE SPEED REDUCER CONTRA ANGLE
K970953 · Nsk Nakanishi, Inc. · Apr 1997