Cleared Traditional

K992326 - 3M CLINPRO SEALANT

K992326 is the FDA 510(k) clearance for 3M CLINPRO SEALANT by 3M Company. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K992326 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
87d
Days
Class 2
Risk

K992326 is an FDA 510(k) clearance for the 3M CLINPRO SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on October 8, 1999 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Company devices

Submission Details

510(k) Number K992326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1999
Decision Date October 08, 1999
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
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 K992326.
HELIOSEAL CLEAR CHROMA
K011491 · Ivoclar North America, Inc. · Aug 2001
ULTRASEAL XT PLUS
K993846 · Ultradent Products, Inc. · Feb 2000
NRC NON-RINSE CONDITIONER
K992519 · Dentsply Intl. · Oct 1999
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K992518 · Dentsply Intl. · Sep 1999
DYRACT SEAL COMPOMER PIT & FISSURE SEALANT
K992516 · Dentsply Intl. · Aug 1999
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
K991909 · Dentsply Intl. · Aug 1999