Cleared Traditional

K915654 - KERALLOY-D CAPS

K915654 is an FDA 510(k) clearance for KERALLOY-D CAPS, manufactured by Wilde-USA, Inc.. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K915654 · Wilde-USA, Inc. · Dental device
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Mar 1992
Decision
75d
Days
Class 2
Risk

K915654 is an FDA 510(k) clearance for the KERALLOY-D CAPS. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Wilde-USA, Inc. (Chicago, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 75 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.

FDA 510(k) Submission Details - K915654

510(k) Number K915654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1991
Decision Date March 02, 1992
Days to Decision 75 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
53d faster than avg
Panel avg: 128d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJJ Device Classification - Class 2, Special Controls

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 62
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K915654.
GK DENTAL AMALGAM ALLOY
K923640 · The Patron Trading Corp. · Feb 1993
ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED
K923384 · L.C. Dental · Jan 1993
AMALGAPHASE
K921538 · Saskan Amalgam Alloys, Inc. · Aug 1992
MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES
K913175 · G-C Intl. Corp. · Dec 1991
KERALLOY NON-GAMMA 2 AMALGAM
K912992 · Wilde-USA, Inc. · Nov 1991
DW 236
K905204 · Ivoclar North America, Inc. · Mar 1991
K915654 · KERALLOY-D CAPS
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