Cleared Traditional

K901256 - AMALCAP PLUS

K901256 is the FDA 510(k) clearance for AMALCAP PLUS by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EJJ) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K901256 · Ivoclar North America, Inc. · Dental device
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Apr 1990
Decision
43d
Days
Class 2
Risk

K901256 is an FDA 510(k) clearance for the AMALCAP PLUS. 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 April 27, 1990 after a review of 43 days - a notably fast clearance cycle.

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: 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 Ivoclar North America, Inc. devices

Submission Details

510(k) Number K901256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1990
Decision Date April 27, 1990
Days to Decision 43 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
84d faster than avg
Panel avg: 127d · This submission: 43d
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 K901256.
LUXALLOY CAPS (PREDOSED CAPSULES)
K902248 · Degussa AG · Jul 1990
LUXALLOY 50 (POWDER, TABLETS, PREDOSED CAPSULES)
K902249 · Degussa AG · Jul 1990
VIVAALLOY HR (AMALGAM)
K901911 · Ivoclar North America, Inc. · Jun 1990
PENT CAPS
K890662 · Jeneric/Pentron, Inc. · May 1989
OROSPHERE PLUS
K890682 · Jeneric/Pentron, Inc. · May 1989
OROSPHERE HCDP
K890681 · Jeneric/Pentron, Inc. · May 1989