O Co., Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “O Co., Inc.” (first 1989, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 108 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 | 16 | 16 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Dental (17)
Most recent O Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033392 | IMMEDIATE STABILIZING IMPLANT (ISI) | DZE | 2003-12-10 | 48 |
| K023336 | OCO DENTAL IMPLANT (5.0MM DIAMETER) | DZE | 2002-10-09 | 2 |
| K021460 | OCO DENTAL IMPLANT | NHA | 2002-05-22 | 15 |
| K011524 | IMMEDIATE STABILIZING DEVICE (ISD) | DZE | 2002-04-10 | 328 |
| K010142 | OCO DENTAL IMPLANT | DZE | 2001-02-01 | 15 |
| K973926 | O BUTMENT HS IMPLANT | DZE | 1998-01-05 | 82 |
| K961665 | O BUTMENT ET IMPLANT | DZE | 1996-11-15 | 199 |
| K950066 | DENTAL IMPLANT ENDOSSEOUS | DZE | 1995-09-15 | 249 |
| K946129 | IMPLANT BODY DEPTH GAUGE/TRYIN | DZE | 1995-03-01 | 75 |
| K946113 | IMPLANT BODY RETRIEVER/REMOVER | DZE | 1995-03-01 | 76 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named O Co., Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under O Co., Inc.?
FDA lists 17 510(k) clearances under the applicant name “O Co., Inc.” (first 1989, latest 2003), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by O Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name O Co., Inc. is 108 days.
Which FDA product codes appear under O Co., Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 16); NHA (Abutment, Implant, Dental, Endosseous, 1).
Next steps
- See all 17 O Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, O Co., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.