Cleared Traditional

K790788 - FISSURE SEALER AND BONDING AGENT

K790788 is the FDA 510(k) clearance for FISSURE SEALER AND BONDING AGENT by Scientific Pharmaceuticals, Inc.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K790788 · Scientific Pharmaceuticals, Inc. · Dental device
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Jul 1979
Decision
73d
Days
Class 2
Risk

K790788 is an FDA 510(k) clearance for the FISSURE SEALER AND BONDING AGENT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1979 after a review of 73 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 Scientific Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K790788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1979
Decision Date July 06, 1979
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 127d · This submission: 73d
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 76
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K790788.
DELTON LIGHT CURING PIT & FISSURE
K831380 · Johnson & Johnson Professionals, Inc. · Jun 1983
PRISMA SEAL
K802562 · Dentsply Intl. · Nov 1980
DELTON* PIT AND FISSURE SEALENT
K790935 · Johnson & Johnson Professionals, Inc. · Aug 1979
ENAMEL BOND SYSTEM
K790596 · Wallace A. Erickson & Co. · Jun 1979
UVIOFIL
K771327 · Espe GmbH (Us) · Aug 1977