Cleared Traditional

PALASPLINT (K953743) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953743 · Heraeus Kulzer, Inc. · Dental device
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Oct 1995
Decision
54d
Days
Class 2
Risk

K953743 is an FDA 510(k) clearance for the PALASPLINT. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on October 2, 1995 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K953743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1995
Decision Date October 02, 1995
Days to Decision 54 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
73d faster than avg
Panel avg: 127d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 89
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K953743.
LIQCRYLIC PRO DENTAL RESIN
K972573 · Dentsply Intl. · Sep 1997
TRUBYTE SOFT RELINE SYSTEM
K964040 · Dentsply Intl. · Dec 1996
QUICKSPLINT
K961995 · Heraeus Kulzer, Inc. · Jun 1996
PRECISE DENTURE BASE RESIN
K952351 · Dentsply Intl. · Jul 1995
DUAL CURE RELINE MATERIAL
K926406 · Dentsply Intl. · Mar 1993
PALABOND
K924422 · Heraeus Kulzer, Inc. · Nov 1992