Cleared Traditional

PARTIAL DENTURE ALLOY (K833512) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833512 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1983
Decision
77d
Days
Class 2
Risk

K833512 is an FDA 510(k) clearance for the PARTIAL DENTURE ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Dentsply Intl. (Walker, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 77 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 Dentsply Intl. devices

Submission Details

510(k) Number K833512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1983
Decision Date December 27, 1983
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 9
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K833512.
ARGELITE 81SF+
K934768 · Argen Precious Metals, Inc. · Dec 1993
PARTIAL DENTURE ALLOY
K860437 · Dentsply Intl. · Mar 1986
BASE METAL ALLOY
K842551 · Dentsply Intl. · Aug 1984
NICKEL-BASED DENTAL CASTING ALLOY
K820328 · Dentsply Intl. · Mar 1982
BASE METAL ALLOY
K811258 · Dentsply Intl. · Jul 1981
CROWN & BRIDGE ALLOY
K772256 · Johnson & Johnson Professionals, Inc. · Jan 1978