Cleared Traditional

K851569 - VERA BOND NON PERCIOUS CERAMIC ALLOY

K851569 is the FDA 510(k) clearance for VERA BOND NON PERCIOUS CERAMIC ALLOY by Aalba Dent, Inc.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K851569 · Aalba Dent, Inc. · Dental device
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May 1985
Decision
42d
Days
Class 2
Risk

K851569 is an FDA 510(k) clearance for the VERA BOND NON PERCIOUS CERAMIC ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Aalba Dent, Inc. (Chicago, US). The FDA issued a Cleared decision on May 29, 1985 after a review of 42 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 Aalba Dent, Inc. devices

Submission Details

510(k) Number K851569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1985
Decision Date May 29, 1985
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 127d · This submission: 42d
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 36
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K851569.
RX ASPEN
K882170 · Jeneric/Pentron, Inc. · Jun 1988
PARTIAL DENTURE ALLOY
K860437 · Dentsply Intl. · Mar 1986
GDC 1453 CASTING ALLOY
K854285 · Deringer-Ney, Inc. · Dec 1985
BASE METAL ALLOY
K842551 · Dentsply Intl. · Aug 1984
PARTIAL DENTURE ALLOY
K833512 · Dentsply Intl. · Dec 1983
NICKEL-BASED DENTAL CASTING ALLOY
K820328 · Dentsply Intl. · Mar 1982