Cleared Traditional

K950894 - SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)

K950894 is an FDA 510(k) clearance for SUREFIRE PF+ (HIGH PALLADIUM DENTAL CAS..., manufactured by Argen Precious Metals, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K950894 · Argen Precious Metals, Inc. · Dental device
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Mar 1995
Decision
32d
Days
Class 2
Risk

K950894 is an FDA 510(k) clearance for the SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS). Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Argen Precious Metals, Inc. (San Diego, US). The FDA issued a Cleared decision on March 31, 1995 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 Argen Precious Metals, Inc. devices

FDA 510(k) Submission Details - K950894

510(k) Number K950894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1995
Decision Date March 31, 1995
Days to Decision 32 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
95d faster than avg
Panel avg: 127d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 99
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K950894.
REMANIUM:GM 700, GM 380, GM 800, GFH
K952867 · Dentauraum, Inc. · Jul 1995
REMANIUM: CS & G-SOFT
K952870 · Dentauraum, Inc. · Jul 1995
REMANIUM: 200,CS, 380, AND CD
K952865 · Dentauraum, Inc. · Jul 1995
VERABOND V
K945712 · Aalba Dent, Inc. · Dec 1994
VERABOND II
K945713 · Aalba Dent, Inc. · Dec 1994
VERABOND III
K945714 · Aalba Dent, Inc. · Dec 1994