510(k) Report

FDA applicant

Implant Innovations International, Inc.

West Palm Beach, FL18 decisions1987–19957 recalls

FDA records 18 decisions for Implant Innovations International, Inc. (West Palm Beach, FL) from 1987 to 1995: 18 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and JES (Floss, Dental). 7 recalls are linked to its devices.

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

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Implant Innovations International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Implant Innovations International, Inc. since 2007.

Recalls per year

6in 2015

2009: 12015: 6
2007high 6 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Implant Innovations International, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Implant Innovations International, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form13decisions
  • JESFloss, Dental1decision
  • EJRAgent, Polishing, Abrasive, Oral Cavity1decision
  • EKJBurnisher, Operative1decision
  • EHZEvacuator, Oral Cavity1decision
  • EFDAmalgamator, Dental, Ac-Powered1decision

Who builds on its devices?

Later devices cite its devices 46 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K932123Implant Innovation Pre-Angled Abutment SystemImplant Innovations International, Inc. · 199414cite it
  • K9355443I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 199513cite it
  • K874590Innovative Implants and Cover ScrewsImplant Innovations International, Inc. · 19889cite it
  • K891613Overdenture AttachmentImplant Innovations International, Inc. · 19893cite it
  • K871954Abutment Head PostImplant Innovations International, Inc. · 19872cite it
  • K891615Surgical DrillsImplant Innovations International, Inc. · 19892cite it

What has FDA decided for it lately?

  • K9355443I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
  • K932123Implant Innovation Pre-Angled Abutment SystemImplant Innovations International, Inc. · 1994
  • K911655ImplaretteImplant Innovations International, Inc. · 1991
  • K905303Abutment GloImplant Innovations International, Inc. · 1991
  • K911701G-Floss & G-Floss IIImplant Innovations International, Inc. · 1991
  • K891613Overdenture AttachmentImplant Innovations International, Inc. · 19896 recalls
  • K891612Drilling Machine W/Handpieces & Internal Irriga.Implant Innovations International, Inc. · 1989
  • K891617Insertion ToolsImplant Innovations International, Inc. · 1989

All 18 as Implant Innovations International, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K891613DAL-RO Housing, Female Assembly Dental implantsNov 25, 2015Class II
  • K891613DAL-RO Threaded Female Dental implantsNov 25, 2015Class II
  • K891613O-Ring Abutment 4.1mm (D) x 4mm (H) Item: OSO40 Dental implantsNov 25, 2015Class II
  • K891613O-Ring Abutment 4.1mm (D) x 2mm (H) Item: OSO20 Dental implantsNov 25, 2015Class II
  • K891613DAL-RO Abutment Dental implantsNov 25, 2015Class II
  • K891613O-Ring Abutment 4.1mm (D) x 6mm (H) Item: OSO60 Dental implantsNov 25, 2015Class II

Other applicant names beginning “Implant”

FDA records each applicant name separately; these may or may not be the same firm.

Implant Innovations, Inc. 51Implant Center of the Palm Beaches 32Implant Direct Sybron Manufacturing, LLC 17Implant Technology, Inc. 13Implant Support Systems, Inc. 10Implant Direct, LLC 10Implant Protesis Dental 2004, S.L. 6Implant Sciences Corp. 6Implant Integration Systems, Inc. 4Implant Logistics, Inc. 3Implant Corp. of America 3Implant Solutions Pty Ltd (Aka Osteon Medical) 2