Implant Innovations International, Inc.: FDA clearances and approvals
Implant Innovations International, Inc. has 18 FDA 510(k) clearances (first 1987, latest 1995), across 6 product codes in 1 review panel. Median 510(k) review time: 72 days.
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 | 13 | 13 |
| EFD | Amalgamator, Dental, Ac-Powered | 1 | 1 |
| EHZ | Evacuator, Oral Cavity | 1 | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 1 |
| EKJ | Burnisher, Operative | 1 | 1 |
| JES | Floss, Dental | 1 | 1 |
Review panels
- Dental (18)
Most recent Implant Innovations International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935544 | 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION | DZE | 1995-03-13 | 486 |
| K932123 | IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM | DZE | 1994-05-27 | 389 |
| K911655 | IMPLARETTE | EKJ | 1991-10-21 | 192 |
| K905303 | ABUTMENT GLO | EJR | 1991-06-10 | 194 |
| K911701 | G-FLOSS & G-FLOSS II | JES | 1991-05-15 | 29 |
| K891613 | OVERDENTURE ATTACHMENT | DZE | 1989-10-10 | 204 |
| K891612 | DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. | EFD | 1989-06-12 | 84 |
| K891617 | INSERTION TOOLS | DZE | 1989-05-01 | 42 |
| K891618 | TITANIUM FORCEPS | DZE | 1989-04-17 | 28 |
| K891615 | SURGICAL DRILLS | DZE | 1989-04-17 | 28 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Implant Innovations International, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Implant Innovations International, Inc. have?
Implant Innovations International, Inc. has 18 FDA 510(k) clearances (first 1987, latest 1995), across 6 product codes in 1 review panel.
How long does FDA take to clear Implant Innovations International, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Implant Innovations International, Inc.'s cleared 510(k)s is 72 days.
What devices does Implant Innovations International, Inc. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 13); EFD (Amalgamator, Dental, Ac-Powered, 1); EHZ (Evacuator, Oral Cavity, 1).
Has Implant Innovations International, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Implant Innovations International, Inc. Related entities may recall under other names.
Next steps
- See all 18 Implant Innovations International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Implant Innovations International, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.