Cleared Traditional

K993846 - ULTRASEAL XT PLUS

K993846 is the FDA 510(k) clearance for ULTRASEAL XT PLUS by Ultradent Products, Inc.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K993846 · Ultradent Products, Inc. · Dental device
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Feb 2000
Decision
96d
Days
Class 2
Risk

K993846 is an FDA 510(k) clearance for the ULTRASEAL XT PLUS. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 16, 2000 after a review of 96 days - within the typical 510(k) review window.

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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K993846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date February 16, 2000
Days to Decision 96 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
31d faster than avg
Panel avg: 127d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 62
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K993846.
REVOTEK LC
K012542 · GC America, Inc. · Oct 2001
TEETHMATE F-1
K012742 · Kuraray Medical, Inc. · Sep 2001
HELIOSEAL CLEAR CHROMA
K011491 · Ivoclar North America, Inc. · Aug 2001
NRC NON-RINSE CONDITIONER
K992519 · Dentsply Intl. · Oct 1999
3M CLINPRO SEALANT
K992326 · 3M Company · Oct 1999
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K992518 · Dentsply Intl. · Sep 1999