Cleared Traditional

PALAVIT L (K905058) - FDA 510(k) Clearance

Class I Dental device.

K905058 · Kulzer, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 127d · This submission: 210d
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

Devices cleared under the same product code (EBH) and FDA review panel - the closest regulatory comparables to K905058.
LC TRAY MATERIAL
K923979 · Dentsply Intl. · Nov 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
P-10 POSTERIOR FILLING MATERIAL
K802751 · 3M Company · Nov 1980