Cleared Traditional

K880875 - VITALLIUM EQUIPOISE ALLOY

K880875 is an FDA 510(k) clearance for VITALLIUM EQUIPOISE ALLOY, manufactured by Austenal Dental, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K880875 · Austenal Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
37d
Days
Class 2
Risk

K880875 is an FDA 510(k) clearance for the VITALLIUM EQUIPOISE ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Austenal Dental, Inc. (Chicago, US). The FDA issued a Cleared decision on April 7, 1988 after a review of 37 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 Austenal Dental, Inc. devices

FDA 510(k) Submission Details - K880875

510(k) Number K880875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date April 07, 1988
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
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 86
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K880875.
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
K903008 · Vident · Sep 1990
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K896501 · Leach and Dillon Co., Inc. · Feb 1990
RX ASPEN
K882170 · Jeneric/Pentron, Inc. · Jun 1988
A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)
K864826 · Austenal Dental, Inc. · Feb 1987
NPG NONPRECIOUS CROWN AND BRIDGE ALLOY
K863782 · Aalba Dent, Inc. · Nov 1986
REXILLIUM N. B. F.
K862822 · Jeneric Ind. · Sep 1986