Cleared Traditional

OSTEOPOWER SYSTEM AND ACCESSORIES

K971692 · Osteomed Corp. · Dental
Jun 1997
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K971692 is an FDA 510(k) clearance for the OSTEOPOWER SYSTEM AND ACCESSORIES, a Handpiece, Rotary Bone Cutting (Class II — Special Controls, product code KMW), submitted by Osteomed Corp. (Irving, US). The FDA issued a Cleared decision on June 27, 1997, 51 days after receiving the submission on May 7, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K971692 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1997
Decision Date June 27, 1997
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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