Cleared Traditional

K800390 - ANT. & POST. RESTORATIVE POWDER LIQ.

K800390 is an FDA 510(k) clearance for ANT. & POST. RESTORATIVE POWDER LIQ., manufactured by American Dental Research. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K800390 · American Dental Research · Dental device
Download Printable Device Report (PDF)
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Apr 1980
Decision
50d
Days
Class 2
Risk

K800390 is an FDA 510(k) clearance for the ANT. & POST. RESTORATIVE POWDER LIQ.. Classified as Agent, Tooth Bonding, Resin (product code KLE), 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 872.3200 - 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 - K800390

510(k) Number K800390 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.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 386
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K800390.
INSTANT BRIDGE
K802333 · Scientific Pharmaceuticals, Inc. · Nov 1980
DEN-MAT DENTIN BONDING AGENT
K801216 · Den-Mat Corp. · May 1980
PRISMA-BOND
K801093 · Dentsply Intl. · May 1980
VISIO-BOND
K790833 · Espe GmbH (Us) · Apr 1979
UVIOBOND
K771328 · Espe GmbH (Us) · Aug 1977
NIMETIC ETCHING GEL
K771325 · Espe GmbH (Us) · Aug 1977