Cleared Traditional

K914513 - PALAVIT G

K914513 is an FDA 510(k) clearance for PALAVIT G, manufactured by Heraeus Kulzer, Inc.. The device is a Class 1 Dental device with product code EGD cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K914513 · Heraeus Kulzer, Inc. · Dental device
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Mar 1992
Decision
162d
Days
Class 1
Risk

K914513 is an FDA 510(k) clearance for the PALAVIT G. Classified as Wax, Dental, Intraoral (product code EGD), Class I - General Controls.

Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on March 19, 1992 after a review of 162 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6890 - 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

FDA 510(k) Submission Details - K914513

510(k) Number K914513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1991
Decision Date March 19, 1992
Days to Decision 162 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
35d slower than avg
Panel avg: 127d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

EGD Device Classification - Class 1, General Controls

Product Code EGD Wax, Dental, Intraoral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6890
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.