Cleared Traditional

K890433 - IMPLANT PARALLELING DEVICE (I.P.D.)

K890433 is an FDA 510(k) clearance for IMPLANT PARALLELING DEVICE (I.P.D.), manufactured by J.E. Josephson, D.M.D.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K890433 · J.E. Josephson, D.M.D. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
140d
Days
Class 1
Risk

K890433 is an FDA 510(k) clearance for the IMPLANT PARALLELING DEVICE (I.P.D.). Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by J.E. Josephson, D.M.D. (Washington, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all J.E. Josephson, D.M.D. devices

FDA 510(k) Submission Details - K890433

510(k) Number K890433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1989
Decision Date June 16, 1989
Days to Decision 140 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 128d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EFB Handpiece, Air-powered, Dental

All 202
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K890433.
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TUBING HANDPIECE REPLACEMENT
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MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL
K850597 · Micro-Aire Surgical Instruments, Inc. · Mar 1985