Implant Innovations, Inc.: FDA filings under this applicant name
FDA lists 51 510(k) clearances under the applicant name “Implant Innovations, Inc.” (first 1994, latest 2007), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 37 | 37 |
| NHA | Abutment, Implant, Dental, Endosseous | 7 | 7 |
| JEY | Plate, Bone | 4 | 4 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
Review panels
- Dental (50)
- Clinical Chemistry (1)
Most recent Implant Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062636 | OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS | DZE | 2007-06-01 | 269 |
| K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS | DZE | 2007-04-30 | 175 |
| K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE | DZE | 2007-04-24 | 175 |
| K063403 | CONICAL ANGLED ABUTMENT | NHA | 2007-03-20 | 131 |
| K061629 | CERTAIN PREVAIL DENTAL IMPLANT | DZE | 2007-02-23 | 256 |
| K062432 | NANOTITE DENTAL IMPLANTS | DZE | 2007-02-22 | 185 |
| K061969 | PREFORMANCE POSTS AND TEMPORARY CYLINDERS | NHA | 2006-07-21 | 9 |
| K061177 | PROVIDE TEMPORARY CYLINDER | NHA | 2006-05-16 | 19 |
| K060291 | PREFORMANCE TEMPORARY CYLINDER | NHA | 2006-02-27 | 21 |
| K053170 | PREFORMANCE POSTS | NHA | 2006-02-01 | 79 |
41 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2004-10-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Implant Center of the Palm Beaches (20 510(k)s)
- Implant Innovations International, Inc. (18 510(k)s)
- Implant Direct Sybron Manufacturing, LLC (17 510(k)s)
- Implant Technology, Inc. (13 510(k)s)
- Implant Direct, LLC (10 510(k)s)
- Implant Support Systems, Inc. (10 510(k)s)
- Implant Protesis Dental 2004, S.L. (6 510(k)s)
- Implant Sciences Corp. (6 510(k)s)
- Implant Integration Systems, Inc. (4 510(k)s)
- Implant Corp. of America (3 510(k)s)
- Implant Logistics, Inc. (3 510(k)s)
- Implant Resource, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Implant Innovations, Inc.?
FDA lists 51 510(k) clearances under the applicant name “Implant Innovations, Inc.” (first 1994, latest 2007), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Implant Innovations, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Implant Innovations, Inc. is 87 days.
Which FDA product codes appear under Implant Innovations, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 37); NHA (Abutment, Implant, Dental, Endosseous, 7); JEY (Plate, Bone, 4).
Next steps
- See all 51 Implant Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Implant Innovations, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.