Cleared Traditional

K882399 - ASEPTIP

K882399 is an FDA 510(k) clearance for ASEPTIP, manufactured by Koppa Innovative Dental Products, Inc.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K882399 · Koppa Innovative Dental Products, Inc. · Dental device
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Jun 1988
Decision
11d
Days
Class 1
Risk

K882399 is an FDA 510(k) clearance for the ASEPTIP. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Koppa Innovative Dental Products, Inc. (Spokane, US). The FDA issued a Cleared decision on June 21, 1988 after a review of 11 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 Koppa Innovative Dental Products, Inc. devices

FDA 510(k) Submission Details - K882399

510(k) Number K882399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1988
Decision Date June 21, 1988
Days to Decision 11 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 128d · This submission: 11d
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 K882399.
BENDA BRUSH
K885162 · Centrix, Inc. · Jan 1989
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K882821 · 3M Company · Sep 1988
CENTRIX NEEDLETUBE
K882651 · Centrix, Inc. · Aug 1988
EXAMIX DISPENSER
K880849 · G-C Intl. Corp. · May 1988
DENTALVISION TV SYSTEM
K880542 · Dentsply Intl. · May 1988
DISPOSABLE DENTAL PROBE/EXPLORER
K880590 · Baxter Healthcare Corp · Mar 1988