Cleared Traditional

K831293 - SOLARCRYL CUSTOM TRAY MATERIAL

K831293 is an FDA 510(k) clearance for SOLARCRYL CUSTOM TRAY MATERIAL, manufactured by Solar Dental Co., Inc.. The device is a Class 1 Dental device with product code EBH cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K831293 · Solar Dental Co., Inc. · Dental device
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Jul 1983
Decision
97d
Days
Class 1
Risk

K831293 is an FDA 510(k) clearance for the SOLARCRYL CUSTOM TRAY MATERIAL. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by Solar Dental Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3670 - 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 - K831293

510(k) Number K831293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1983
Decision Date July 26, 1983
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 128d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

EBH Device Classification - Class 1, General Controls

Product Code EBH Material, Impression Tray, Resin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3670
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EBH Material, Impression Tray, Resin

All 15
Devices cleared under the same product code (EBH) and FDA review panel - the closest regulatory comparables to K831293.
IMPRESSION TRAY
K872210 · Dentsply Intl. · Jun 1987
RESIN TRAY IMPRESSION MATERIAL
K854042 · Dentsply Intl. · Nov 1985
VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE
K844471 · Dentsply Intl. · Feb 1985
HYBRID DENTAL PRODUCT
K813550 · Dentsply Intl. · Feb 1982
SR-IVOLEN
K810686 · J. Aderer, Inc. · Apr 1981
P-10 POSTERIOR FILLING MATERIAL
K802751 · 3M Company · Nov 1980