Cleared Traditional

K902115 - PALAPRESS(R) VARIO RESIN

K902115 is an FDA 510(k) clearance for PALAPRESS VARIO RESIN, manufactured by Kulzer, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K902115 · Kulzer, Inc. · Dental device
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Jul 1990
Decision
78d
Days
Class 2
Risk

K902115 is an FDA 510(k) clearance for the PALAPRESS(R) VARIO RESIN. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Kulzer, Inc. (Chicago, US). The FDA issued a Cleared decision on July 27, 1990 after a review of 78 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 Kulzer, Inc. devices

FDA 510(k) Submission Details - K902115

510(k) Number K902115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1990
Decision Date July 27, 1990
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

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 259
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K902115.
MODERN MATERIALS ORTHODONTIC RESIN
K913699 · Heraeus Kulzer, Inc. · Oct 1991
MELIODENT, DENTURE RESIN
K910465 · Heraeus Kulzer, Inc. · Jun 1991
NEW TRIAD TRANSHEET DENTURE BASE MATERIAL
K905702 · Dentsply Intl. · Apr 1991
PALADON(R) 65
K901789 · Kulzer, Inc. · Jun 1990
PALFIQUE LIGHT LINER
K896980 · Tokuyama America, Inc. · May 1990
TOKUSO REBASE
K896981 · Tokuyama America, Inc. · May 1990