Cleared Traditional

K802751 - P-10 POSTERIOR FILLING MATERIAL

K802751 is the FDA 510(k) clearance for P-10 POSTERIOR FILLING MATERIAL by 3M Company. It is a Class 1 Dental device (product code EBH) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K802751 · 3M Company · Dental device
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Nov 1980
Decision
9d
Days
Class 1
Risk

K802751 is an FDA 510(k) clearance for the P-10 POSTERIOR FILLING MATERIAL. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3670 - 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.

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Submission Details

510(k) Number K802751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1980
Decision Date November 12, 1980
Days to Decision 9 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
118d faster than avg
Panel avg: 127d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBH Material, Impression Tray, Resin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3670
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.