Cleared Traditional

K934768 - ARGELITE 81SF+

K934768 is the FDA 510(k) clearance for ARGELITE 81SF+ by Argen Precious Metals, Inc.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K934768 · Argen Precious Metals, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
66d
Days
Class 2
Risk

K934768 is an FDA 510(k) clearance for the ARGELITE 81SF+. 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 December 10, 1993 after a review of 66 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

Submission Details

510(k) Number K934768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1993
Decision Date December 10, 1993
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K934768.
R2+
K934758 · Jeneric/Pentron, Inc. · Feb 1994
ARGELOY PARTIAL (NON-PRECIOUS)
K935829 · Argen Precious Metals, Inc. · Jan 1994
ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION)
K935972 · Argen Precious Metals, Inc. · Jan 1994
R1, R2, AND R1+
K922954 · Jeneric/Pentron, Inc. · Jul 1993
DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.
K920561 · Ivoclar North America, Inc. · Mar 1992
ROCATEC(R) -PLUS
K913857 · Espe GmbH (Us) · Dec 1991