Cleared Traditional

K820456 - CROWN & BRIDGE RESIN FOR FABRICAT/DE

K820456 is an FDA 510(k) clearance for CROWN & BRIDGE RESIN FOR FABRICAT/DE, manufactured by Rohm and Haas Co.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K820456 · Rohm and Haas Co. · Dental device
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Mar 1982
Decision
28d
Days
Class 2
Risk

K820456 is an FDA 510(k) clearance for the CROWN & BRIDGE RESIN FOR FABRICAT/DE. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Rohm and Haas Co. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1982 after a review of 28 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 Rohm and Haas Co. devices

FDA 510(k) Submission Details - K820456

510(k) Number K820456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1982
Decision Date March 19, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 128d · This submission: 28d
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 K820456.
INTERIM TEMP. CROWN & BRIDGE RESIN
K833261 · Coe Laboratories, Inc. · Jan 1984
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