Cleared Traditional

K911655 - IMPLARETTE

K911655 is an FDA 510(k) clearance for IMPLARETTE, manufactured by Implant Innovations International, Inc.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 192-day FDA review.

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

FDA 510(k) Submission Details - K911655

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 127d · This submission: 192d
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 19
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K911655.
AMD DENTIST AND HYGIENIST KITS
K925115 · Advance Medical Designs, Inc. · Jul 1994
APPLICATOR NOZZLE
K926368 · Centrix, Inc. · Sep 1993
PART 872 DEGUFILL H & DEGUFILL M DA
K914368 · Degussa AG · Nov 1991
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · Premier Dental Products Co. · Jun 1991
PULPDENT PIC N STIC
K911281 · Pulpdent Corp. · May 1991
MIRROR SHIELD
K901053 · Pulpdent Corp. · May 1990