Cleared Traditional

FRIOS MICROSAW

K994298 · Friadent GmbH · Dental
Feb 2000
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K994298 is an FDA 510(k) clearance for the FRIOS MICROSAW, a Handpiece, Rotary Bone Cutting (Class II — Special Controls, product code KMW), submitted by Friadent GmbH (Lake Forest, US). The FDA issued a Cleared decision on February 18, 2000, 59 days after receiving the submission on December 21, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K994298 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1999
Decision Date February 18, 2000
Days to Decision 59 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

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