Cleared Traditional

K994298 - FRIOS MICROSAW

K994298 is an FDA 510(k) clearance for FRIOS MICROSAW, manufactured by Friadent GmbH. The device is a Class 2 Dental device with product code KMW cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K994298 · Friadent GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
59d
Days
Class 2
Risk

K994298 is an FDA 510(k) clearance for the FRIOS MICROSAW. Classified as Handpiece, Rotary Bone Cutting (product code KMW), Class II - Special Controls.

Submitted by Friadent GmbH (Lake Forest, US). The FDA issued a Cleared decision on February 18, 2000 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K994298

510(k) Number K994298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 128d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KMW Device Classification - Class 2, Special Controls

Product Code KMW Handpiece, Rotary Bone Cutting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KMW Handpiece, Rotary Bone Cutting

All 7
Devices cleared under the same product code (KMW) and FDA review panel - the closest regulatory comparables to K994298.
Surgical Angle Handpiece, Surgical Straight Handpiece
K171155 · Nakanishi, Inc. · Nov 2017
OsteoMed PINNACLE Driver
K162544 · Osteomed · Apr 2017
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
K080939 · W&H Dentalwerk Buermoos GmbH · Jul 2008
OSTEOPOWER SYSTEM AND ACCESSORIES
K971692 · Osteomed Corp. · Jun 1997
E-TYPE SPEED REDUCER CONTRA ANGLE
K970953 · Nsk Nakanishi, Inc. · Apr 1997
YOUNG D'GRANULATOR
K932255 · Young Dental Manufacturing Co. 1, LLC · Apr 1994