Cleared Traditional

CUSHIONS, DENTURE ADHESIVE, ALL-DAY (K770413) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K770413 · Combe, Inc. · Dental device
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Jun 1977
Decision
112d
Days
Class 2
Risk

K770413 is an FDA 510(k) clearance for the CUSHIONS, DENTURE ADHESIVE, ALL-DAY. Classified as Cushion, Denture, Over The Counter (product code EHS), Class II - Special Controls.

Submitted by Combe, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1977 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3540 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Combe, Inc. devices

Submission Details

510(k) Number K770413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1977
Decision Date June 24, 1977
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EHS Cushion, Denture, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3540
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.