Cleared Traditional

K831294 - SOLARCRY/TEMPORARY CROWN & BRIDGE MAT

K831294 is an FDA 510(k) clearance for SOLARCRY/TEMPORARY CROWN & BRIDGE MAT, manufactured by Solar Dental Co., Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K831294 · Solar Dental Co., Inc. · Dental device
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Aug 1983
Decision
133d
Days
Class 2
Risk

K831294 is an FDA 510(k) clearance for the SOLARCRY/TEMPORARY CROWN & BRIDGE MAT. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Solar Dental Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 133 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 Solar Dental Co., Inc. devices

FDA 510(k) Submission Details - K831294

510(k) Number K831294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1983
Decision Date August 31, 1983
Days to Decision 133 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 128d · This submission: 133d
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 167
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K831294.
INTEGRITY
K853052 · Dentsply Intl. · Aug 1985
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