Company ยท US
Implant Innovations, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2007. Name variants (Inc, Corp, punctuation) are merged.
51510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 1, 2007 | K062636 | OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Apr 30, 2007 | K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Apr 24, 2007 | K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE Implant Innovations, Inc. | DZE |
| Mar 20, 2007 | K063403 | CONICAL ANGLED ABUTMENT Implant Innovations, Inc. | NHA |
| Feb 23, 2007 | K061629 | CERTAIN PREVAIL DENTAL IMPLANT Implant Innovations, Inc. | DZE |
| Feb 22, 2007 | K062432 | NANOTITE DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Jul 21, 2006 | K061969 | PREFORMANCE POSTS AND TEMPORARY CYLINDERS Implant Innovations, Inc. | NHA |
| May 16, 2006 | K061177 | PROVIDE TEMPORARY CYLINDER Implant Innovations, Inc. | NHA |
| Feb 27, 2006 | K060291 | PREFORMANCE TEMPORARY CYLINDER Implant Innovations, Inc. | NHA |
| Feb 1, 2006 | K053170 | PREFORMANCE POSTS Implant Innovations, Inc. | NHA |
| Oct 20, 2005 | K052648 | MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS Implant Innovations, Inc. | NHA |
| Sep 15, 2005 | K051461 | 3I OSSEOTITE DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Jun 8, 2005 | K051189 | PREVAIL DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Jun 16, 2004 | K041402 | MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS Implant Innovations, Inc. | DZE |
| Mar 24, 2004 | K034035 | 3I PATIENT-SPECIFIC OVERDENTURE BAR Implant Innovations, Inc. | NHA |
| Jan 28, 2004 | K032263 | 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR Implant Innovations, Inc. | DZE |
| Nov 7, 2003 | K033430 | 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 Implant Innovations, Inc. | DZE |
| Sep 16, 2003 | K031632 | OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS Implant Innovations, Inc. | DZE |
| Sep 15, 2003 | K030614 | 3I DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Jul 28, 2003 | K031475 | OSSEOTITE NT CERTAIN IMPLANTS Implant Innovations, Inc. | DZE |
| Dec 30, 2002 | K022009 | 3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Sep 19, 2002 | K022113 | 3I DENTAL IMPLANT ACCESSORIES Implant Innovations, Inc. | DZE |
| May 16, 2002 | K014235 | OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES Implant Innovations, Inc. | DZE |
| Dec 17, 2001 | K013570 | OSSEOTITE DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Sep 28, 2001 | K012911 | 3I LOCATER ABUTMENT SYSTEM Implant Innovations, Inc. | DZE |
| Sep 19, 2001 | K012047 | 3I CALCIUM SULFATE BONE CEMENT Implant Innovations, Inc. | LYC |
| Feb 1, 2000 | K994148 | 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM Implant Innovations, Inc. | JQC |
| Oct 8, 1999 | K992334 | ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING Implant Innovations, Inc. | DZE |
| Sep 29, 1999 | K991947 | 3I CERAMIC ABUTMENT SYSTEM Implant Innovations, Inc. | DZE |
| Jan 6, 1999 | K983347 | OSSEOTITE DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Aug 17, 1998 | K980083 | 3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT Implant Innovations, Inc. | DZE |
| Apr 28, 1998 | K980549 | OSSEOTITE DENTAL IMPLANT SYSTEM Implant Innovations, Inc. | DZE |
| Dec 23, 1997 | K972480 | 3I BIORESORBABLE FIXATION TACK Implant Innovations, Inc. | DZL |
| Dec 4, 1997 | K973771 | DENTAL/SURGICAL DRILLS, BURS, TAPS Implant Innovations, Inc. | DZE |
| Aug 26, 1997 | K972444 | 3I INNOVATIVE IMPLANTS AND COVER SCREWS Implant Innovations, Inc. | DZE |
| Mar 17, 1997 | K965077 | SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS Implant Innovations, Inc. | DZE |
| Oct 18, 1996 | K962014 | 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC. Implant Innovations, Inc. | DZE |
| Sep 20, 1996 | K962465 | TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS Implant Innovations, Inc. | DZE |
| Aug 1, 1996 | K960417 | 3I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS/3 I EMERGENCE PROF. TEMP. HEALING ABUTMENTS Implant Innovations, Inc. | DZE |
| Apr 4, 1996 | K960914 | 3I OSSEOUS FIXATION SYSTEM(S) Implant Innovations, Inc. | JEY |
| Apr 1, 1996 | K954347 | 3I STANDARD THREADED IMPLANT Implant Innovations, Inc. | DZE |
| Feb 9, 1996 | K955427 | 3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS Implant Innovations, Inc. | DZE |
| Feb 8, 1996 | K955428 | 3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS Implant Innovations, Inc. | DZE |
| Sep 27, 1995 | K950204 | 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM) Implant Innovations, Inc. | DZE |
| Sep 15, 1995 | K953386 | 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS Implant Innovations, Inc. | JEY |
| Aug 30, 1995 | K952812 | 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS Implant Innovations, Inc. | JEY |
| Aug 30, 1995 | K952811 | 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS Implant Innovations, Inc. | JEY |
| Jun 30, 1995 | K951553 | 3I ASYST ABUTMENT PACKAGE SYSTEM Implant Innovations, Inc. | DZE |
| Apr 26, 1994 | K933969 | TAPERED ABUTMENT AND RELATED COMPONENTS Implant Innovations, Inc. | DZE |
| Apr 25, 1994 | K934126 | ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS Implant Innovations, Inc. | DZE |
Newest 50 of 51.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2004 | Implant Innovations, Inc. EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant. Terminated |
DZE | K934126 |
| Jul 20, 2004 | Implant Innovations, Inc. Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 56 Terminated |
DZI | None listed |
| Jul 20, 2004 | Implant Innovations, Inc. Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 56 Terminated |
DZI | None listed |
| Jul 20, 2004 | Implant Innovations, Inc. Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 56 Terminated |
DZI | None listed |
| Jul 20, 2004 | Implant Innovations, Inc. Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 56 Terminated |
DZI | None listed |
| Jul 20, 2004 | Implant Innovations, Inc. Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 56 Terminated |
DZI | None listed |
| Jun 17, 2003 | Implant Innovations, Inc. Products are surgical drills packaged separately or included in a surgical kit so two products will be listed.
The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 Osseo Terminated |
DZE | None listed |
| Jun 17, 2003 | Implant Innovations, Inc. Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be Terminated |
DZE | None listed |
| Mar 20, 2003 | Implant Innovations, Inc. LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile, Terminated |
DZE | K950204 |