Cleared Traditional

K991239 - VIP 60 (2H)

K991239 is an FDA 510(k) clearance for VIP 60 (2H), manufactured by Micron Corp.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K991239 · Micron Corp. · Dental device
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Oct 1999
Decision
189d
Days
Class 2
Risk

K991239 is an FDA 510(k) clearance for the VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Micron Corp. (Ota-Ku, Tokyo, JP). The FDA issued a Cleared decision on October 18, 1999 after a review of 189 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 Micron Corp. devices

FDA 510(k) Submission Details - K991239

510(k) Number K991239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1999
Decision Date October 18, 1999
Days to Decision 189 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 127d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
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 - ELC Scaler, Ultrasonic

All 82
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K991239.
PREMIER ULTRASONIC SCALER AND INSERTS
K010195 · Premier Dental Products Co. · Apr 2001
VECTOR
K002122 · Air Techniques, Inc. · Dec 2000
DELSONIC 2000
K990546 · Sds Dental, Inc. · Nov 1999
BIOSONIC ULTRASONIC SCALER SYSTEM
K983727 · Coltene/Whaledent, Inc. · Jan 1999
SP4044 & SP4055 LUX MODULES
K972026 · Satelec · Jul 1997
DENTSPLY CAVITRON SPS SCALER SYSTEM
K970123 · Dentsply Intl. · Apr 1997