Cleared Traditional

K882651 - CENTRIX NEEDLETUBE

K882651 is an FDA 510(k) clearance for CENTRIX NEEDLETUBE, manufactured by Centrix, Inc.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K882651 · Centrix, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
44d
Days
Class 1
Risk

K882651 is an FDA 510(k) clearance for the CENTRIX NEEDLETUBE. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Centrix, Inc. (Milford, US). The FDA issued a Cleared decision on August 10, 1988 after a review of 44 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.

FDA 510(k) Submission Details - K882651

510(k) Number K882651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1988
Decision Date August 10, 1988
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 128d · This submission: 44d
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 71
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K882651.
BREVET DENTAL INSTRUMENTS
K883126 · Brevet, Inc. · Oct 1988
VITRABOND LIGHT CURE GLASS IONOMER LINER
K882821 · 3M Company · Sep 1988
DENTAL HAND INSTRUMENTS
K883322 · Collagen Corp. · Aug 1988
TISSUE PUNCH
K882834 · Tri-Stage, Inc. · Aug 1988
SYRETTE
K881992 · Oratec Corp. · Jul 1988
THE DIRECTION DIAL
K882309 · Lawhorn Innovations · Jun 1988
K882651 · CENTRIX NEEDLETUBE
Download PDF Centrix, Inc.