Cleared Traditional

K801047 - PLY LESIVE

K801047 is an FDA 510(k) clearance for PLY LESIVE, manufactured by May-Pell Chemical Development Co.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K801047 · May-Pell Chemical Development Co. · Dental device
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May 1980
Decision
15d
Days
Class 2
Risk

K801047 is an FDA 510(k) clearance for the PLY LESIVE. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by May-Pell Chemical Development Co. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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 May-Pell Chemical Development Co. devices

FDA 510(k) Submission Details - K801047

510(k) Number K801047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1980
Decision Date May 20, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 128d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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.