Cleared Traditional

K883126 - BREVET DENTAL INSTRUMENTS

K883126 is an FDA 510(k) clearance for BREVET DENTAL INSTRUMENTS, manufactured by Brevet, Inc.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K883126 · Brevet, Inc. · Dental device
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Oct 1988
Decision
71d
Days
Class 1
Risk

K883126 is an FDA 510(k) clearance for the BREVET DENTAL INSTRUMENTS. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Brevet, Inc. (Anahem, US). The FDA issued a Cleared decision on October 5, 1988 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Brevet, Inc. devices

FDA 510(k) Submission Details - K883126

510(k) Number K883126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date October 05, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

EKJ Device Classification - Class 1, General Controls

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKJ Burnisher, Operative

All 23
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K883126.
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