Cleared Traditional

K992648 - ROTARY MASTER

K992648 is an FDA 510(k) clearance for ROTARY MASTER, manufactured by J. Morita USA, Inc.. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K992648 · J. Morita USA, Inc. · Dental device
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Jan 2000
Decision
178d
Days
Class 1
Risk

K992648 is an FDA 510(k) clearance for the ROTARY MASTER. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on January 31, 2000 after a review of 178 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all J. Morita USA, Inc. devices

FDA 510(k) Submission Details - K992648

510(k) Number K992648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1999
Decision Date January 31, 2000
Days to Decision 178 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
51d slower than avg
Panel avg: 127d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

EBW Device Classification - Class 1, General Controls

Product Code EBW Controller, Foot, Handpiece And Cord
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EBW Controller, Foot, Handpiece And Cord

All 50
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K992648.
SURGIC IV IMPLANT CONTROL UNIT
K020327 · Nakanishi, Inc. · Apr 2002
ELEC-MATE E
K011926 · Nakanishi, Inc. · Sep 2001
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
K002469 · W&H Dentalwerk Buermoos GmbH · Feb 2001
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
K990954 · Nsk Nakanishi, Inc. · Jun 1999
ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)
K972889 · W & H Dentalwerk · Jan 1998
SURGIC II IMPLANT CONTROL UNIT
K972924 · Nsk Nakanishi, Inc. · Oct 1997