Cleared Traditional

IMPLARETTE (K911655) - FDA 510(k) Clearance

Class I Dental device.

K911655 · Implant Innovations International, Inc. · Dental device
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Oct 1991
Decision
192d
Days
Class 1
Risk

K911655 is an FDA 510(k) clearance for the IMPLARETTE. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Implant Innovations International, Inc. (West Palm Beach, US). The FDA issued a Cleared decision on October 21, 1991 after a review of 192 days - an extended review 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: 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 Implant Innovations International, Inc. devices

Submission Details

510(k) Number K911655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1991
Decision Date October 21, 1991
Days to Decision 192 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 127d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K911655.
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