Cleared Traditional

K971692 - OSTEOPOWER SYSTEM AND ACCESSORIES

K971692 is an FDA 510(k) clearance for OSTEOPOWER SYSTEM AND ACCESSORIES, manufactured by Osteomed Corp.. The device is a Class 2 Dental device with product code KMW cleared through the Traditional 510(k) pathway after a 51-day FDA review.

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

K971692 is an FDA 510(k) clearance for the OSTEOPOWER SYSTEM AND ACCESSORIES. Classified as Handpiece, Rotary Bone Cutting (product code KMW), Class II - Special Controls.

Submitted by Osteomed Corp. (Irving, US). The FDA issued a Cleared decision on June 27, 1997 after a review of 51 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.

View all Osteomed Corp. devices

FDA 510(k) Submission Details - K971692

510(k) Number K971692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 127d · This submission: 51d
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 K971692.
OsteoMed PINNACLE Driver
K162544 · Osteomed · Apr 2017
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
K080939 · W&H Dentalwerk Buermoos GmbH · Jul 2008
FRIOS MICROSAW
K994298 · Friadent GmbH · Feb 2000
E-TYPE SPEED REDUCER CONTRA ANGLE
K970953 · Nsk Nakanishi, Inc. · Apr 1997
YOUNG D'GRANULATOR
K932255 · Young Dental Manufacturing Co. 1, LLC · Apr 1994