Cleared Traditional

K011822 - PIT AND FISSURE CHEMICAL CURING SEALANT

K011822 is an FDA 510(k) clearance for PIT AND FISSURE CHEMICAL CURING SEALANT, manufactured by Rite-Dent Manufacturing Corp.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K011822 · Rite-Dent Manufacturing Corp. · Dental device
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Aug 2001
Decision
57d
Days
Class 2
Risk

K011822 is an FDA 510(k) clearance for the PIT AND FISSURE CHEMICAL CURING SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Rite-Dent Manufacturing Corp. (Hialeah, US). The FDA issued a Cleared decision on August 7, 2001 after a review of 57 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 Rite-Dent Manufacturing Corp. devices

FDA 510(k) Submission Details - K011822

510(k) Number K011822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2001
Decision Date August 07, 2001
Days to Decision 57 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
70d faster than avg
Panel avg: 127d · This submission: 57d
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 105
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K011822.
TEETHMATE F-1
K012742 · Kuraray Medical, Inc. · Sep 2001
OPTIBOND SOLO PLUS 3
K011908 · Kerr Dental Materials Center · Sep 2001
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
3M CLINPRO SEALANT
K992326 · 3M Company · Oct 1999