Cleared Traditional

K800828 - MYERSON'S SPECIAL CROWN & BRIDGE RESIN

K800828 is an FDA 510(k) clearance for MYERSON'S SPECIAL CROWN & BRIDGE RESIN, manufactured by Myerson Tooth Corp.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800828 · Myerson Tooth Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1980
Decision
15d
Days
Class 2
Risk

K800828 is an FDA 510(k) clearance for the MYERSON'S SPECIAL CROWN & BRIDGE RESIN. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Myerson Tooth Corp. (Walker, US). The FDA issued a Cleared decision on April 29, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 - K800828

510(k) Number K800828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1980
Decision Date April 29, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 128d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 169
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K800828.
DENTALON
K831077 · Kulzer, Inc. · Sep 1983
PROTEMP
K822452 · Espe GmbH (Us) · Sep 1982
SILANIT
K802679 · Vivadent (Usa), Inc. · Dec 1980
TEMP. CROWN MSTERIAL FOR TEETH
K781244 · Den-Mat Corp. · Aug 1978
MYERSONS SPEC. CROWN & BRIDGE RESIN
K771602 · Howmedica Corp. · Aug 1977
ACCU. CROWN COLD CURE
K771527 · Parker Laboratories, Inc. · Aug 1977