Cleared Traditional

K932012 - CAPS

K932012 is an FDA 510(k) clearance for CAPS, manufactured by Chemichl, Inc.. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K932012 · Chemichl, Inc. · Dental device
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Nov 1993
Decision
194d
Days
Class 2
Risk

K932012 is an FDA 510(k) clearance for the CAPS. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Chemichl, Inc. (Woodinville, US). The FDA issued a Cleared decision on November 3, 1993 after a review of 194 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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 Chemichl, Inc. devices

FDA 510(k) Submission Details - K932012

510(k) Number K932012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1993
Decision Date November 03, 1993
Days to Decision 194 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 127d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELL Device Classification - Class 2, Special Controls

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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.

Regulatory Peers - ELL Teeth, Porcelain

All 31
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K932012.
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TYCERAMIC
K910569 · Jeneric/Pentron, Inc. · Apr 1991