Cleared Traditional

K823744 - PORCELAIN ARTIFICIAL TEETH

K823744 is the FDA 510(k) clearance for PORCELAIN ARTIFICIAL TEETH by Dentsply Intl.. It is a Class 2 Dental device (product code ELL) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K823744 · Dentsply Intl. · Dental device
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Dec 1982
Decision
15d
Days
Class 2
Risk

K823744 is an FDA 510(k) clearance for the PORCELAIN ARTIFICIAL TEETH. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentsply Intl. devices

Submission Details

510(k) Number K823744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1982
Decision Date December 28, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
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 26
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K823744.
DEN-MAT PORETCH (PORCELAIN ETCHANT)
K875351 · Den-Mat Corp. · Mar 1988
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN
K864724 · Dentsply Intl. · Feb 1987
ARTIFICIAL TEETH, PORCELAIN, MODIFIED
K860608 · Dentsply Intl. · Mar 1986
NU-GLAZE
K781935 · Deringer-Ney, Inc. · Dec 1978
BIOBOND MASTER STAIN AND GLAZE KIT
K771179 · Dentsply Intl. · Jul 1977