Cleared Traditional

K924982 - CONSEPSIS(TM)

K924982 is the FDA 510(k) clearance for CONSEPSIS(TM) by Ultradent Products, Inc.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K924982 · Ultradent Products, Inc. · Dental device
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Jul 1993
Decision
280d
Days
Class 2
Risk

K924982 is an FDA 510(k) clearance for the CONSEPSIS(TM). Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 280 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K924982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1992
Decision Date July 08, 1993
Days to Decision 280 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
153d slower than avg
Panel avg: 127d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 70
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K924982.
FLUOR PROTECTOR
K946032 · Ivoclar North America, Inc. · Mar 1995
BOSWORTH COPALIONER
K933505 · Harry J. Bosworth Co. · Jan 1994
CONSEPSIS SCRUB
K925375 · 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