Cleared Traditional

K924824 - MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE

K924824 is an FDA 510(k) clearance for MICRODOSE PIT AND FISSURE SEALANT-CLEAR..., manufactured by Unicep. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K924824 · Unicep · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
169d
Days
Class 2
Risk

K924824 is an FDA 510(k) clearance for the MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Unicep (Sandpoint, US). The FDA issued a Cleared decision on March 16, 1993 after a review of 169 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 - K924824

510(k) Number K924824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1992
Decision Date March 16, 1993
Days to Decision 169 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
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 109
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K924824.
PRIMADRY PRODUCT LINE
K931868 · Ultradent Products, Inc. · Jul 1993
ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE
K931869 · Ultradent Products, Inc. · Jul 1993
BARITONE C2, MODIFICATION
K932002 · Confi-Dental Products Co. · Jul 1993
ALPHA-DENT PIT AND FISSURE SEALANT
K924635 · Wallace A. Erickson & Co. · Oct 1992
ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN
K921599 · Ultradent Products, Inc. · Sep 1992
ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE
K921600 · Ultradent Products, Inc. · Sep 1992