Cleared Traditional

K983081 - BEGOPAL 300

K983081 is an FDA 510(k) clearance for BEGOPAL 300, manufactured by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K983081 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
56d
Days
Class 2
Risk

K983081 is an FDA 510(k) clearance for the BEGOPAL 300. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO (Bremen, DE). The FDA issued a Cleared decision on October 28, 1998 after a review of 56 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 Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO devices

FDA 510(k) Submission Details - K983081

510(k) Number K983081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1998
Decision Date October 28, 1998
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

Product Code EJS Alloy, Other 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 - EJS Alloy, Other Noble Metal

All 164
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K983081.
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JELFINE-52 (CODE NAME RD-0901)
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SILCAST (CODE NAME RD-0118)
K981247 · J.F. Jelenko & Co., Inc. · Jul 1998
AURENORM 68
K972945 · Aurex Precious Metal Industries (Pty)Ltd · Nov 1997