510(k) Report

510(k) · Cleared

Cleared

Implarette

K911655510(k) TraditionalCleared Oct 21, 1991192-day reviewClass I21 CFR 872.4565

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Implant Innovations International, Inc. · EKJ Burnisher, Operative

Cleared on Oct 21, 1991 after a 192-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 21, 1991
Review
192 days
Class
Class I
Product code
EKJ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K911655Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All EKJ devices

EKJ Burnisher, Operative: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKJ

FDA has decided no EKJ device since 2007.

Median 510(k) review, days · EKJ

Too few EKJ 510(k)s in any year since 2007 to give a median.

Recalls per year · EKJ

No recall names EKJ since 2007.

Adverse event reports per year · EKJ

2in 2015

2011: 12015: 2
2007high 2 (2015) · low 0 (2007)2025

MAUDE reports naming product code EKJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—02
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Implant Innovations International, Inc.

18 FDA decisions under this applicant name. See the company

  • K9355443I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
  • K932123Implant Innovation Pre-Angled Abutment SystemImplant Innovations International, Inc. · 1994
  • K905303Abutment GloImplant Innovations International, Inc. · 1991
  • K911701G-Floss & G-Floss IIImplant Innovations International, Inc. · 1991
  • K891613Overdenture AttachmentImplant Innovations International, Inc. · 19896 recalls

Recent decisions in EKJ

The EKJ category page

  • K961714Aseptylum, Uni-CarrierDistriflor S.A. · 1996
  • K953707Medtrol Dental KitMedtrol, Inc. · 1996
  • K945815Dental KitConstancy Ent., Inc. · 1995
  • K951607Sureflex FilesDentsply Intl. · 1995
  • K945077Instrument,Filling,Plastic,DentalWorldwide Dental, Inc. · 1994

https://510kreport.com/device/K911655 · printed Nov 4, 2026

Cite this page

510(k) Report. “K911655: Implarette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K911655

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026