Cleared Traditional

K983077 - BIO PONTOSTAR

K983077 is an FDA 510(k) clearance for BIO PONTOSTAR, manufactured by Bego U.S.A.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K983077 · Bego U.S.A. · Dental device
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Oct 1998
Decision
51d
Days
Class 2
Risk

K983077 is an FDA 510(k) clearance for the BIO PONTOSTAR. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Bego U.S.A. (Pawtucket, US). The FDA issued a Cleared decision on October 23, 1998 after a review of 51 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 U.S.A. devices

FDA 510(k) Submission Details - K983077

510(k) Number K983077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1998
Decision Date October 23, 1998
Days to Decision 51 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
76d faster than avg
Panel avg: 127d · This submission: 51d
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 K983077.
MAINBOND A
K984140 · J.F. Jelenko & Co., Inc. · Jan 1999
AUROLLOYD KF
K983080 · Bego U.S.A. · Oct 1998
BEGOCER G
K983082 · Bego U.S.A. · Oct 1998
PLATINLLOYD 100
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AUROFLUID CPF
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BW-1 (CODE NAME RD-0807)
K981244 · J.F. Jelenko & Co., Inc. · Aug 1998