Cleared Traditional

CS-11 (K832500) - FDA 510(k) Clearance

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

K832500 · Chema-Scutum, Inc. · Dental device
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Oct 1983
Decision
92d
Days
Class 2
Risk

K832500 is an FDA 510(k) clearance for the CS-11. Classified as Coating, Denture Hydrophilic, Resin (product code EBE), Class II - Special Controls.

Submitted by Chema-Scutum, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1983 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3300 - 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 Chema-Scutum, Inc. devices

Submission Details

510(k) Number K832500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1983
Decision Date October 27, 1983
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBE Coating, Denture Hydrophilic, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3300
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.