Cleared Traditional

K851733 - DENTAL PORCELAIN-VARIOUS

K851733 is an FDA 510(k) clearance for DENTAL PORCELAIN-VARIOUS, manufactured by Excelco Intl., Inc.. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 174-day FDA review.

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

FDA 510(k) Submission Details - K851733

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
46d slower than avg
Panel avg: 128d · This submission: 174d
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 K851733.
DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM
K871808 · Degussa Dental, Inc. · Jun 1987
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
NU-GLAZE
K781935 · Deringer-Ney, Inc. · Dec 1978
BIOBOND MASTER STAIN AND GLAZE KIT
K771179 · Dentsply Intl. · Jul 1977