Cleared Traditional

K901782 - CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM

K901782 is an FDA 510(k) clearance for CONVERTRAY CUSTOM IMPRESSION TRAY MATER..., manufactured by Productivity Training Corp.. The device is a Class 1 Dental device with product code EBH cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K901782 · Productivity Training Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
73d
Days
Class 1
Risk

K901782 is an FDA 510(k) clearance for the CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by Productivity Training Corp. (Chicago, US). The FDA issued a Cleared decision on June 29, 1990 after a review of 73 days - a notably fast clearance cycle.

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: 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 Productivity Training Corp. devices

FDA 510(k) Submission Details - K901782

510(k) Number K901782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1990
Decision Date June 29, 1990
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 127d · This submission: 73d
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 K901782.
PALADISC LC
K923549 · Heraeus Kulzer, Inc. · Sep 1992
PALAVIT L
K905058 · Kulzer, Inc. · Jun 1991
PALATRAY LC RESIN IMPRESSION TRAY MATERIAL
K902350 · Kulzer, Inc. · Jul 1990
MODIFIED PERMAGUM ADHESIVE
K881838 · Espe GmbH (Us) · Jul 1988
PERMADYNE ADHESIVE
K875228 · Espe GmbH (Us) · Mar 1988
IMPREGUM F ADHESIVE
K875257 · Espe GmbH (Us) · Mar 1988