Cleared Traditional

K800391 - PAINT-ON-RESTORATIVE W/FISSURE SEALER

K800391 is an FDA 510(k) clearance for PAINT-ON-RESTORATIVE W/FISSURE SEALER, manufactured by American Dental Research. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K800391 · American Dental Research · Dental device
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Apr 1980
Decision
50d
Days
Class 2
Risk

K800391 is an FDA 510(k) clearance for the PAINT-ON-RESTORATIVE W/FISSURE SEALER. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by American Dental Research (Mchenry, US). The FDA issued a Cleared decision on April 10, 1980 after a review of 50 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 American Dental Research devices

FDA 510(k) Submission Details - K800391

510(k) Number K800391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1980
Decision Date April 10, 1980
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 128d · This submission: 50d
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 K800391.
HELIOSEAL
K813015 · Vivadent (Usa), Inc. · Dec 1981
CONTACT SEAL
K802682 · Vivadent (Usa), Inc. · Nov 1980
PRISMA SEAL
K802562 · Dentsply Intl. · Nov 1980
DELTON* PIT AND FISSURE SEALENT
K790935 · Johnson & Johnson Professionals, Inc. · Aug 1979
FISSURE SEALER AND BONDING AGENT
K790788 · Scientific Pharmaceuticals, Inc. · Jul 1979
ENAMEL BOND SYSTEM
K790596 · Wallace A. Erickson & Co. · Jun 1979