Cleared Traditional

K890811 - RX APF (CASTING ALLOY)

K890811 is an FDA 510(k) clearance for RX APF (CASTING ALLOY), manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K890811 · Jeneric/Pentron, Inc. · Dental device
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Mar 1989
Decision
29d
Days
Class 2
Risk

K890811 is an FDA 510(k) clearance for the RX APF (CASTING ALLOY). Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on March 17, 1989 after a review of 29 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K890811

510(k) Number K890811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1989
Decision Date March 17, 1989
Days to Decision 29 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
98d faster than avg
Panel avg: 127d · This submission: 29d
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 156
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K890811.
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
PROTOCOL (ALLOY)
K901099 · Ivoclar North America, Inc. · Apr 1990
ALBABOND E
K883511 · Degussa Dental, Inc. · Oct 1988
HERAEUS DG 63
K883509 · Degussa Dental, Inc. · Sep 1988
HERAEUS C SPECIAL
K883507 · Degussa Dental, Inc. · Sep 1988