Cleared Traditional

K903317 - DENTALON PLUS

K903317 is the FDA 510(k) clearance for DENTALON PLUS by Kulzer, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K903317 · Kulzer, Inc. · Dental device
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Aug 1990
Decision
19d
Days
Class 2
Risk

K903317 is an FDA 510(k) clearance for the DENTALON PLUS. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on August 13, 1990 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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

Submission Details

510(k) Number K903317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1990
Decision Date August 13, 1990
Days to Decision 19 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
108d faster than avg
Panel avg: 127d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 101
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K903317.
FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL
K934978 · Ivoclar North America, Inc. · Dec 1993
PALAVIT 55 AND DENTACOLOR CONNECTOR
K932034 · Heraeus Kulzer, Inc. · Aug 1993
ACUFEX ENDOFIX BUTTON
K922559 · Acufex Microsurgical, Inc. · Dec 1992
PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)
K901077 · Scientific Pharmaceuticals, Inc. · May 1990
PROTEMP II
K900436 · Espe GmbH (Us) · Mar 1990
CAVIT-W
K875133 · Espe GmbH (Us) · Mar 1988