Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Implant Innovations, Inc. · Predicate Candidate Screening
51 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
234 days90th percentile
51clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062636 | OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTA | Implant Innovations, Inc. | 2007-06-01 | 269 | 0 |
| K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS | Implant Innovations, Inc. | 2007-04-30 | 175 | 9 |
| K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE | Implant Innovations, Inc. | 2007-04-24 | 175 | 4 |
| K063403 | CONICAL ANGLED ABUTMENT | Implant Innovations, Inc. | 2007-03-20 | 131 | 5 |
| K061629 | CERTAIN PREVAIL DENTAL IMPLANT | Implant Innovations, Inc. | 2007-02-23 | 256 | 0 |
| K062432 | NANOTITE DENTAL IMPLANTS | Implant Innovations, Inc. | 2007-02-22 | 185 | 0 |
| K061969 | PREFORMANCE POSTS AND TEMPORARY CYLINDERS | Implant Innovations, Inc. | 2006-07-21 | 9 | 2 |
| K061177 | PROVIDE TEMPORARY CYLINDER | Implant Innovations, Inc. | 2006-05-16 | 19 | 0 |
| K060291 | PREFORMANCE TEMPORARY CYLINDER | Implant Innovations, Inc. | 2006-02-27 | 21 | 3 |
| K053170 | PREFORMANCE POSTS | Implant Innovations, Inc. | 2006-02-01 | 79 | 3 |
| K052648 | MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVE | Implant Innovations, Inc. | 2005-10-20 | 24 | 1 |
| K051461 | 3I OSSEOTITE DENTAL IMPLANTS | Implant Innovations, Inc. | 2005-09-15 | 104 | 0 |
| K051189 | PREVAIL DENTAL IMPLANTS | Implant Innovations, Inc. | 2005-06-08 | 29 | 0 |
| K041402 | MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS | Implant Innovations, Inc. | 2004-06-16 | 21 | 0 |
| K034035 | 3I PATIENT-SPECIFIC OVERDENTURE BAR | Implant Innovations, Inc. | 2004-03-24 | 86 | 0 |
| K032263 | 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR | Implant Innovations, Inc. | 2004-01-28 | 189 | 1 |
| K033430 | 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, | Implant Innovations, Inc. | 2003-11-07 | 10 | 0 |
| K031632 | OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS | Implant Innovations, Inc. | 2003-09-16 | 112 | 0 |
| K030614 | 3I DENTAL IMPLANTS | Implant Innovations, Inc. | 2003-09-15 | 201 | 0 |
| K031475 | OSSEOTITE NT CERTAIN IMPLANTS | Implant Innovations, Inc. | 2003-07-28 | 80 | 0 |
| K022009 | 3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL | Implant Innovations, Inc. | 2002-12-30 | 194 | 0 |
| K022113 | 3I DENTAL IMPLANT ACCESSORIES | Implant Innovations, Inc. | 2002-09-19 | 83 | 0 |
| K014235 | OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES | Implant Innovations, Inc. | 2002-05-16 | 141 | 0 |
| K013570 | OSSEOTITE DENTAL IMPLANTS | Implant Innovations, Inc. | 2001-12-17 | 52 | 0 |
| K012911 | 3I LOCATER ABUTMENT SYSTEM | Implant Innovations, Inc. | 2001-09-28 | 29 | 10 |
| K012047 | 3I CALCIUM SULFATE BONE CEMENT | Implant Innovations, Inc. | 2001-09-19 | 82 | 0 |
| K994148 | 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM | Implant Innovations, Inc. | 2000-02-01 | 55 | 0 |
| K992334 | ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING | Implant Innovations, Inc. | 1999-10-08 | 87 | 0 |
| K991947 | 3I CERAMIC ABUTMENT SYSTEM | Implant Innovations, Inc. | 1999-09-29 | 112 | 0 |
| K983347 | OSSEOTITE DENTAL IMPLANTS | Implant Innovations, Inc. | 1999-01-06 | 105 | 0 |
| K980083 | 3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT | Implant Innovations, Inc. | 1998-08-17 | 220 | 0 |
| K980549 | OSSEOTITE DENTAL IMPLANT SYSTEM | Implant Innovations, Inc. | 1998-04-28 | 90 | 0 |
| K972480 | 3I BIORESORBABLE FIXATION TACK | Implant Innovations, Inc. | 1997-12-23 | 175 | 0 |
| K973771 | DENTAL/SURGICAL DRILLS, BURS, TAPS | Implant Innovations, Inc. | 1997-12-04 | 63 | 0 |
| K972444 | 3I INNOVATIVE IMPLANTS AND COVER SCREWS | Implant Innovations, Inc. | 1997-08-26 | 57 | 2 |
| K965077 | SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE | Implant Innovations, Inc. | 1997-03-17 | 90 | 0 |
| K962014 | 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC. | Implant Innovations, Inc. | 1996-10-18 | 148 | 0 |
| K962465 | TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS | Implant Innovations, Inc. | 1996-09-20 | 87 | 0 |
| K960417 | 3I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS | Implant Innovations, Inc. | 1996-08-01 | 185 | 0 |
| K960914 | 3I OSSEOUS FIXATION SYSTEM(S) | Implant Innovations, Inc. | 1996-04-04 | 29 | 0 |
| K954347 | 3I STANDARD THREADED IMPLANT | Implant Innovations, Inc. | 1996-04-01 | 196 | 0 |
| K955427 | 3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING | Implant Innovations, Inc. | 1996-02-09 | 73 | 0 |
| K955428 | 3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING I | Implant Innovations, Inc. | 1996-02-08 | 72 | 0 |
| K950204 | 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLA | Implant Innovations, Inc. | 1995-09-27 | 252 | 2 |
| K953386 | 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE | Implant Innovations, Inc. | 1995-09-15 | 58 | 0 |
| K952811 | 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL | Implant Innovations, Inc. | 1995-08-30 | 72 | 0 |
| K952812 | 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VI | Implant Innovations, Inc. | 1995-08-30 | 72 | 0 |
| K951553 | 3I ASYST ABUTMENT PACKAGE SYSTEM | Implant Innovations, Inc. | 1995-06-30 | 87 | 0 |
| K933969 | TAPERED ABUTMENT AND RELATED COMPONENTS | Implant Innovations, Inc. | 1994-04-26 | 253 | 0 |
| K934126 | ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUT | Implant Innovations, Inc. | 1994-04-25 | 243 | 7 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda