Cleared Traditional

K901099 - PROTOCOL (ALLOY)

K901099 is an FDA 510(k) clearance for PROTOCOL (ALLOY), manufactured by Ivoclar North America, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K901099 · Ivoclar North America, Inc. · Dental device
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Apr 1990
Decision
49d
Days
Class 2
Risk

K901099 is an FDA 510(k) clearance for the PROTOCOL (ALLOY). Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on April 25, 1990 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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

FDA 510(k) Submission Details - K901099

510(k) Number K901099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date April 25, 1990
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

Product Code EJS Alloy, Other Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJS Alloy, Other Noble Metal

All 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K901099.
ARGENCO 34
K903060 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO Y (TYPE III/IV DENTAL ALLOY CROWN/BRIDGE
K902665 · Argen Precious Metals, Inc. · Aug 1990
DW231 DENTAL ALLOY
K902376 · Ivoclar North America, Inc. · Jun 1990
RX APF (CASTING ALLOY)
K890811 · Jeneric/Pentron, Inc. · Mar 1989
ALBABOND E
K883511 · Degussa Dental, Inc. · Oct 1988
HERAEUS DG 63
K883509 · Degussa Dental, Inc. · Sep 1988