Cleared Traditional

K800829 - MYERSON R&KENSON R PORCELAIN ANT&POS.-

K800829 is an FDA 510(k) clearance for MYERSON R&KENSON R PORCELAIN ANT&POS.-, manufactured by Myerson Tooth Corp.. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K800829 · Myerson Tooth Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1980
Decision
24d
Days
Class 2
Risk

K800829 is an FDA 510(k) clearance for the MYERSON R&KENSON R PORCELAIN ANT&POS.-. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Myerson Tooth Corp. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1980 after a review of 24 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 Myerson Tooth Corp. devices

FDA 510(k) Submission Details - K800829

510(k) Number K800829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1980
Decision Date May 08, 1980
Days to Decision 24 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 128d · This submission: 24d
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 K800829.
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