Cleared Traditional

K905058 - PALAVIT L

K905058 is an FDA 510(k) clearance for PALAVIT L, manufactured by Kulzer, Inc.. The device is a Class 1 Dental device with product code EBH cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K905058 · Kulzer, Inc. · Dental device
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Jun 1991
Decision
210d
Days
Class 1
Risk

K905058 is an FDA 510(k) clearance for the PALAVIT L. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 210 days - an extended review 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: 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 Kulzer, Inc. devices

FDA 510(k) Submission Details - K905058

510(k) Number K905058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1990
Decision Date June 06, 1991
Days to Decision 210 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 127d · This submission: 210d
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 14
Devices cleared under the same product code (EBH) and FDA review panel - the closest regulatory comparables to K905058.
PALATRAY LC MINT
K930487 · Heraeus Kulzer, Inc. · Jun 1993
LC TRAY MATERIAL
K923979 · Dentsply Intl. · Nov 1992
PALADISC LC
K923549 · Heraeus Kulzer, Inc. · Sep 1992
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