Cleared Traditional

K833261 - INTERIM TEMP. CROWN & BRIDGE RESIN

K833261 is the FDA 510(k) clearance for INTERIM TEMP. CROWN & BRIDGE RESIN by Coe Laboratories, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K833261 · Coe Laboratories, Inc. · Dental device
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Jan 1984
Decision
102d
Days
Class 2
Risk

K833261 is an FDA 510(k) clearance for the INTERIM TEMP. CROWN & BRIDGE RESIN. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Coe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 102 days - within the typical 510(k) review window.

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: 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 Coe Laboratories, Inc. devices

Submission Details

510(k) Number K833261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1983
Decision Date January 03, 1984
Days to Decision 102 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 127d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 104
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K833261.
CAVIT-W
K875133 · Espe GmbH (Us) · Mar 1988
MAR BOND
K875145 · Reliance Orthodontic Products, Inc. · Feb 1988
INTEGRITY
K853052 · Dentsply Intl. · Aug 1985
DENTALON
K831077 · Kulzer, Inc. · Sep 1983
PROTEMP
K822452 · Espe GmbH (Us) · Sep 1982
TEMP. CROWN MSTERIAL FOR TEETH
K781244 · Den-Mat Corp. · Aug 1978