510(k) Report

FDA applicant

Implant Innovations, Inc.

Palm Beach Gardens, FL51 decisions1994–200762 recalls

FDA records 51 decisions for Implant Innovations, Inc. (Palm Beach Gardens, FL) from 1994 to 2007: 51 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 144 predicates, 102 of them its own earlier devices. 62 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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

6in 2007

2007: 6
2007high 6 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

7in 2020

2007: 32008: 12009: 12010: 12011: 22012: 22013: 22015: 332016: 12017: 12019: 52020: 7
2007high 33 (2015) · low 0 (2014)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form37decisions
  • NHAAbutment, Implant, Dental, Endosseous7decisions
  • JEYPlate, Bone4decisions
  • LYCBone Grafting Material, Synthetic1decision
  • DZLScrew, Fixation, Intraosseous1decision
  • JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use1decision

Whose devices does it build on?

Its devices cite 144 predicates; 102 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 231 times; 102 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.

  • K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 200715cite it
  • K933462Conical AbutmentImplant Innovations, Inc. · 199413cite it
  • K934126One and Two Piece Temporary Healing,(Emergence Profile) AbutmentsImplant Innovations, Inc. · 199413cite it
  • K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 200213cite it
  • K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 200211cite it
  • K983347Osseotite Dental ImplantsImplant Innovations, Inc. · 199911cite it

What has FDA decided for it lately?

  • K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP, Microminiplant, Dental ImplantsImplant Innovations, Inc. · 2007
  • K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 200710 recalls
  • K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 20075 recalls
  • K063403Conical Angled AbutmentImplant Innovations, Inc. · 20075 recalls
  • K061629Certain Prevail Dental ImplantImplant Innovations, Inc. · 2007
  • K062432Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
  • K061969Preformance Posts and Temporary CylindersImplant Innovations, Inc. · 20062 recalls
  • K061177Provide Temporary CylinderImplant Innovations, Inc. · 2006

All 51 as Implant Innovations, Inc. →

What has been recalled?

62 recalls linked to its devices; the latest:

  • K052648BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4Aug 31, 2020Class II
  • K052648CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4Aug 31, 2020Class II
  • K052648CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6Aug 31, 2020Class II
  • K052648BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER…Aug 31, 2020Class II
  • K052648CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4Aug 31, 2020Class II
  • K052648CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5Aug 31, 2020Class II

Other applicant names beginning “Implant”

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

Implant Center of the Palm Beaches 32Implant Innovations International, Inc. 18Implant 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