Cleared Traditional

DENTAL PORCELAIN-VARIOUS (K851733) - FDA 510(k) Clearance

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

K851733 · Excelco Intl., Inc. · Dental device
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Oct 1985
Decision
174d
Days
Class 2
Risk

K851733 is an FDA 510(k) clearance for the DENTAL PORCELAIN-VARIOUS. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Excelco Intl., Inc. (Puerto Rico, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 174 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 Excelco Intl., Inc. devices

Submission Details

510(k) Number K851733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date October 16, 1985
Days to Decision 174 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 127d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K851733.
SPECTRUM
K880774 · Dentsply Intl. · May 1988
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN
K864724 · Dentsply Intl. · Feb 1987
ARTIFICIAL TEETH, PORCELAIN, MODIFIED
K860608 · Dentsply Intl. · Mar 1986
PORCELAIN ARTIFICIAL TEETH
K823744 · Dentsply Intl. · Dec 1982
BIOBOND MASTER STAIN AND GLAZE KIT
K771179 · Dentsply Intl. · Jul 1977