Cleared Traditional

JELENKO PORCELAIN SYSTEM PVS PROCELAIN (K923717) - FDA 510(k) Clearance

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

K923717 · J.F. Jelenko & Co., Inc. · Dental device
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Mar 1993
Decision
232d
Days
Class 2
Risk

K923717 is an FDA 510(k) clearance for the JELENKO PORCELAIN SYSTEM PVS PROCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by J.F. Jelenko & Co., Inc. (Armonk, US). The FDA issued a Cleared decision on March 16, 1993 after a review of 232 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 J.F. Jelenko & Co., Inc. devices

Submission Details

510(k) Number K923717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1992
Decision Date March 16, 1993
Days to Decision 232 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
105d slower than avg
Panel avg: 127d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 165
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K923717.
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K954761 · Dentsply Intl. · Nov 1995
SOFTWEAR PORCELAIN SYSTEM
K943582 · Dentsply Intl. · Aug 1994
FINESSE PORCELAIN SYSTEM
K940252 · Dentsply Intl. · Mar 1994
DENTAL PORCELAIN
K921619 · Dentsply Intl. · Jul 1992
NEW OPAQUE PORCELAIN
K915543 · Dentsply Intl. · Mar 1992
OPAQUE PORCELAIN
K900393 · Dentsply Intl. · Apr 1990