Cleared Traditional

K980613 - PROGOLD ELECTROCOPING SYSTEM

K980613 is an FDA 510(k) clearance for PROGOLD ELECTROCOPING SYSTEM, manufactured by Micro Dental Laboratories. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K980613 · Micro Dental Laboratories · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
19d
Days
Class 2
Risk

K980613 is an FDA 510(k) clearance for the PROGOLD ELECTROCOPING SYSTEM. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Micro Dental Laboratories (Dublin, US). The FDA issued a Cleared decision on March 9, 1998 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 Micro Dental Laboratories devices

FDA 510(k) Submission Details - K980613

510(k) Number K980613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1998
Decision Date March 09, 1998
Days to Decision 19 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 127d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJT Alloy, Gold-based Noble Metal

All 549
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K980613.
BW-1 (CODE NAME RD-0807)
K981244 · J.F. Jelenko & Co., Inc. · Aug 1998
BIOGOLD PLUS DENTAL ALLOY
K980660 · European Dental Imports, Inc. · Apr 1998
CARRARA PDF, CARRARA H, CARRARA R
K980597 · European Dental Imports, Inc. · Mar 1998
AURELUX 77
K972946 · Aurex Precious Metal Industries (Pty)Ltd · Dec 1997
AUROFILM 2000
K973372 · Metalor Dental USA Corp. · Nov 1997
PROSPECTOR PLUS (CODE NAME : RD-0508)
K973881 · J.F. Jelenko & Co., Inc. · Nov 1997