Cleared Traditional

K924827 - MICRODOSE POTASSIUM OXYLATE

K924827 is an FDA 510(k) clearance for MICRODOSE POTASSIUM OXYLATE, manufactured by Unicep. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K924827 · Unicep · Dental device
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Mar 1993
Decision
158d
Days
Class 2
Risk

K924827 is an FDA 510(k) clearance for the MICRODOSE POTASSIUM OXYLATE. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Unicep (Sandpoint, US). The FDA issued a Cleared decision on March 5, 1993 after a review of 158 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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 Unicep devices

FDA 510(k) Submission Details - K924827

510(k) Number K924827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1992
Decision Date March 05, 1993
Days to Decision 158 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
31d slower than avg
Panel avg: 127d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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 - LBH Varnish, Cavity

All 115
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K924827.
BOSWORTH COPALIONER
K933505 · Harry J. Bosworth Co. · Jan 1994
CONSEPSIS SCRUB
K925375 · Ultradent Products, Inc. · Jul 1993
CONSEPSIS(TM)
K924982 · Ultradent Products, Inc. · Jul 1993
DENTIN PROTECTOR
K901915 · Ivoclar North America, Inc. · Jun 1990
COPAL VARNISH
K901049 · Pulpdent Corp. · May 1990
UNIVERSUM
K900946 · Scientific Pharmaceuticals, Inc. · May 1990