Cleared Traditional

K951865 - ULTRA SPHERICAL AMALGAM ALLOY

K951865 is an FDA 510(k) clearance for ULTRA SPHERICAL AMALGAM ALLOY, manufactured by Goldsmith & Revere, Inc.. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K951865 · Goldsmith & Revere, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
34d
Days
Class 2
Risk

K951865 is an FDA 510(k) clearance for the ULTRA SPHERICAL AMALGAM ALLOY. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Goldsmith & Revere, Inc. (Englewood, US). The FDA issued a Cleared decision on May 25, 1995 after a review of 34 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.

View all Goldsmith & Revere, Inc. devices

FDA 510(k) Submission Details - K951865

510(k) Number K951865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1995
Decision Date May 25, 1995
Days to Decision 34 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 127d · This submission: 34d
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 46
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K951865.
ARDENT FUTURA NON GAMMA-2
K964775 · Ardent Production Development · Dec 1996
GALLOY
K955285 · Southern Dental Industries, Inc. · Jan 1996
TYTIN R
K951663 · Kerr Corporation (Danbury) · Jun 1995
TYTIN ADMIX
K951511 · Kerr Corporation (Danbury) · May 1995
SYBRALOY
K940675 · Sybron Dental Specialties, Inc. · Apr 1994
TYTIN
K935535 · Kerr Corporation (Danbury) · Mar 1994