Cleared Traditional

K792042 - DENTURE BASE RESIN

K792042 is an FDA 510(k) clearance for DENTURE BASE RESIN, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K792042 · Dentsply Intl. · Dental device
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Nov 1979
Decision
49d
Days
Class 2
Risk

K792042 is an FDA 510(k) clearance for the DENTURE BASE RESIN. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on November 30, 1979 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K792042

510(k) Number K792042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1979
Decision Date November 30, 1979
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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.