Cleared Traditional

K931869 - ULTRASEAL XT PIT AND FISSURE SEALANT PR...

K931869 is the FDA 510(k) clearance for ULTRASEAL XT PIT AND FISSURE SEALANT PR... by Ultradent Products, Inc.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K931869 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
99d
Days
Class 2
Risk

K931869 is an FDA 510(k) clearance for the ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE. 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 July 22, 1993 after a review of 99 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 K931869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1993
Decision Date July 22, 1993
Days to Decision 99 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
28d faster than avg
Panel avg: 127d · This submission: 99d
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 K931869.
PULPDENT SEAL-RITE LOW VISCOSITY
K932794 · Pulpdent Corp. · Sep 1993
HELIOSEAL F
K932078 · Ivoclar North America, Inc. · Sep 1993
PRIMADRY PRODUCT LINE
K931868 · Ultradent Products, Inc. · Jul 1993
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
ESTISEAL LC
K915095 · Heraeus Kulzer, Inc. · Jan 1992