Cleared Traditional

K881333 - OLYMPIA ALLOY

K881333 is an FDA 510(k) clearance for OLYMPIA ALLOY, manufactured by J.F. Jelenko & Co., Inc.. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K881333 · J.F. Jelenko & Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
23d
Days
Class 2
Risk

K881333 is an FDA 510(k) clearance for the OLYMPIA ALLOY. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by J.F. Jelenko & Co., Inc. (Armonk, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 23 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 J.F. Jelenko & Co., Inc. devices

FDA 510(k) Submission Details - K881333

510(k) Number K881333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1988
Decision Date April 21, 1988
Days to Decision 23 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
104d faster than avg
Panel avg: 127d · This submission: 23d
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 45
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K881333.
PENT CAPS
K890662 · Jeneric/Pentron, Inc. · May 1989
OROSPHERE PLUS
K890682 · Jeneric/Pentron, Inc. · May 1989
OROSPHERE HCDP
K890681 · Jeneric/Pentron, Inc. · May 1989
HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY
K875344 · Kulzer, Inc. · Mar 1988
ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2
K870230 · Degussa Dental, Inc. · May 1987
LIMI ALLOY
K844653 · G-C Intl. Corp. · Mar 1985