Cleared Traditional

K934283 - DENTALON PLUS MODIFICATION

K934283 is an FDA 510(k) clearance for DENTALON PLUS MODIFICATION, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K934283 · Heraeus Kulzer, Inc. · Dental device
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Dec 1993
Decision
101d
Days
Class 2
Risk

K934283 is an FDA 510(k) clearance for the DENTALON PLUS MODIFICATION. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on December 10, 1993 after a review of 101 days - within the typical 510(k) review window.

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: 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 - K934283

510(k) Number K934283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date December 10, 1993
Days to Decision 101 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
26d faster than avg
Panel avg: 127d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

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 160
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K934283.
STRUCTUR 2
K941124 · Voco GmbH · Apr 1994
GC TEMPRON
K935960 · GC America, Inc. · Mar 1994
3M TEMPORARY CROWN & BRIDGE MATERIAL
K935041 · 3M Company · Jan 1994
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