Cleared Traditional

PLAKOF (K890910) - FDA 510(k) Clearance

Class I Dental device.

K890910 · Ximex, Ltd. · Dental device
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Mar 1989
Decision
21d
Days
Class 1
Risk

K890910 is an FDA 510(k) clearance for the PLAKOF. Classified as Pick, Massaging (product code JET), Class I - General Controls.

Submitted by Ximex, Ltd. (England Sw13 9nt, GB). The FDA issued a Cleared decision on March 16, 1989 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6650 - 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 Ximex, Ltd. devices

Submission Details

510(k) Number K890910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1989
Decision Date March 16, 1989
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 127d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JET Pick, Massaging
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6650
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.