Not currently registered with FDA under this name
Implant Innovations, Inc.
Palm Beach Gardens, FL, United States. Named as applicant on 50 dental 510(k) clearances between 1994 and 2007. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 501994–2007
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Implant Innovations, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Implant Innovations, Inc. | 50 clearances | 1994–2007 | Below |
| Taiwan | TFDA | Manufacturer | IMPLANT INNOVATIONS INC. | 2 | 2005–2006 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Implant Innovations, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Jun 2007 | K062636 | OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 30 Apr 2007 | K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 24 Apr 2007 | K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE | DZE Root-Form Endosseous Implant |
| 20 Mar 2007 | K063403 | CONICAL ANGLED ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 23 Feb 2007 | K061629 | CERTAIN PREVAIL DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 22 Feb 2007 | K062432 | NANOTITE DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 21 Jul 2006 | K061969 | PREFORMANCE POSTS AND TEMPORARY CYLINDERS | NHA Endosseous Dental Implant Abutment |
| 16 May 2006 | K061177 | PROVIDE TEMPORARY CYLINDER | NHA Endosseous Dental Implant Abutment |
| 27 Feb 2006 | K060291 | PREFORMANCE TEMPORARY CYLINDER | NHA Endosseous Dental Implant Abutment |
| 1 Feb 2006 | K053170 | PREFORMANCE POSTS | NHA Endosseous Dental Implant Abutment |
| 20 Oct 2005 | K052648 | MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS | NHA Endosseous Dental Implant Abutment |
| 15 Sep 2005 | K051461 | 3I OSSEOTITE DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 8 Jun 2005 | K051189 | PREVAIL DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 16 Jun 2004 | K041402 | MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS | DZE Root-Form Endosseous Implant |
| 24 Mar 2004 | K034035 | 3I PATIENT-SPECIFIC OVERDENTURE BAR | NHA Endosseous Dental Implant Abutment |
| 28 Jan 2004 | K032263 | 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR | DZE Root-Form Endosseous Implant |
| 7 Nov 2003 | K033430 | 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 | DZE Root-Form Endosseous Implant |
| 16 Sep 2003 | K031632 | OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS | DZE Root-Form Endosseous Implant |
| 15 Sep 2003 | K030614 | 3I DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 28 Jul 2003 | K031475 | OSSEOTITE NT CERTAIN IMPLANTS | DZE Root-Form Endosseous Implant |
| 30 Dec 2002 | K022009 | 3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 19 Sep 2002 | K022113 | 3I DENTAL IMPLANT ACCESSORIES | DZE Root-Form Endosseous Implant |
| 16 May 2002 | K014235 | OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES | DZE Root-Form Endosseous Implant |
| 17 Dec 2001 | K013570 | OSSEOTITE DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 28 Sep 2001 | K012911 | 3I LOCATER ABUTMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 19 Sep 2001 | K012047 | 3I CALCIUM SULFATE BONE CEMENT | LYC Synthetic Bone Grafting Material |
| 8 Oct 1999 | K992334 | ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING | DZE Root-Form Endosseous Implant |
| 29 Sep 1999 | K991947 | 3I CERAMIC ABUTMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 6 Jan 1999 | K983347 | OSSEOTITE DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 17 Aug 1998 | K980083 | 3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT | DZE Root-Form Endosseous Implant |
| 28 Apr 1998 | K980549 | OSSEOTITE DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 23 Dec 1997 | K972480 | 3I BIORESORBABLE FIXATION TACK | DZL Intraosseous Fixation Screw |
| 4 Dec 1997 | K973771 | DENTAL/SURGICAL DRILLS, BURS, TAPS | DZE Root-Form Endosseous Implant |
| 26 Aug 1997 | K972444 | 3I INNOVATIVE IMPLANTS AND COVER SCREWS | DZE Root-Form Endosseous Implant |
| 17 Mar 1997 | K965077 | SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS | DZE Root-Form Endosseous Implant |
| 18 Oct 1996 | K962014 | 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC. | DZE Root-Form Endosseous Implant |
| 20 Sep 1996 | K962465 | TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS | DZE Root-Form Endosseous Implant |
| 1 Aug 1996 | K960417 | 3I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS/3 I EMERGENCE PROF. TEMP. HEALING ABUTMENTS | DZE Root-Form Endosseous Implant |
| 4 Apr 1996 | K960914 | 3I OSSEOUS FIXATION SYSTEM(S) | JEY Bone Plate |
| 1 Apr 1996 | K954347 | 3I STANDARD THREADED IMPLANT | DZE Root-Form Endosseous Implant |
| 9 Feb 1996 | K955427 | 3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS | DZE Root-Form Endosseous Implant |
| 8 Feb 1996 | K955428 | 3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS | DZE Root-Form Endosseous Implant |
| 27 Sep 1995 | K950204 | 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM) | DZE Root-Form Endosseous Implant |
| 15 Sep 1995 | K953386 | 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS | JEY Bone Plate |
| 30 Aug 1995 | K952812 | 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS | JEY Bone Plate |
| 30 Aug 1995 | K952811 | 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS | JEY Bone Plate |
| 30 Jun 1995 | K951553 | 3I ASYST ABUTMENT PACKAGE SYSTEM | DZE Root-Form Endosseous Implant |
| 26 Apr 1994 | K933969 | TAPERED ABUTMENT AND RELATED COMPONENTS | DZE Root-Form Endosseous Implant |
| 25 Apr 1994 | K934126 | ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS | DZE Root-Form Endosseous Implant |
| 7 Mar 1994 | K933462 | CONICAL ABUTMENT | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: ZimVie US Corp LLC (13), Zest Anchors, LLC (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.