Cleared Traditional

K905204 - DW 236

K905204 is the FDA 510(k) clearance for DW 236 by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EJJ) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K905204 · Ivoclar North America, Inc. · Dental device
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Mar 1991
Decision
129d
Days
Class 2
Risk

K905204 is an FDA 510(k) clearance for the DW 236. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 Ivoclar North America, Inc. devices

Submission Details

510(k) Number K905204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date March 29, 1991
Days to Decision 129 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
2d slower than avg
Panel avg: 127d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
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 - EJJ Alloy, Amalgam

All 21
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K905204.
TYTIN ADMIX
K951511 · Kerr Corporation (Danbury) · May 1995
SYBRALOY
K940675 · Sybron Dental Specialties, Inc. · Apr 1994
TYTIN
K935535 · Kerr Corporation (Danbury) · Mar 1994
DW 235
K905205 · Ivoclar North America, Inc. · Dec 1990
ARTALLOY (POWDER)
K902247 · Degussa AG · Jul 1990
LUXALLOY CAPS (PREDOSED CAPSULES)
K902248 · Degussa AG · Jul 1990