Cleared Traditional

K924982 - CONSEPSIS(TM)

K924982 is an FDA 510(k) clearance for CONSEPSIS(TM), manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K924982

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.

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 101
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