Cleared Traditional

PALATRAY LC MINT (K930487) - FDA 510(k) Clearance

Class I Dental device.

K930487 · Heraeus Kulzer, Inc. · Dental device
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Jun 1993
Decision
140d
Days
Class 1
Risk

K930487 is an FDA 510(k) clearance for the PALATRAY LC MINT. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on June 18, 1993 after a review of 140 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K930487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1993
Decision Date June 18, 1993
Days to Decision 140 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 7
Devices cleared under the same product code (EBH) and FDA review panel - the closest regulatory comparables to K930487.
LC TRAY MATERIAL
K923979 · Dentsply Intl. · Nov 1992
PALADISC LC
K923549 · Heraeus Kulzer, Inc. · Sep 1992
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