Basic Dental Implant Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Basic Dental Implant Systems, Inc.” (first 2001, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 48 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 | 6 | 6 |
Review panels
- Dental (6)
Most recent Basic Dental Implant Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082749 | OMNI-TIGHT | DZE | 2008-12-04 | 76 |
| K072595 | OMNI-TIGHT | DZE | 2008-05-09 | 238 |
| K022912 | POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM | DZE | 2002-09-20 | 17 |
| K013682 | MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM | DZE | 2001-11-28 | 21 |
| K012299 | MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM | DZE | 2001-08-01 | 12 |
| K001259 | 2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM | DZE | 2001-01-12 | 268 |
Recalls
openFDA lists no recalls under a recalling firm named Basic Dental Implant Systems, 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.
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.
- Basic Medical Technology, Inc. (8 510(k)s)
- Basic Intl., Inc. (1 510(k)s)
- Basic Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Basic Dental Implant Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Basic Dental Implant Systems, Inc.” (first 2001, latest 2008), across 1 product code 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 Basic Dental Implant Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Basic Dental Implant Systems, Inc. is 48 days.
Which FDA product codes appear under Basic Dental Implant Systems, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 6).
Next steps
- See all 6 Basic Dental Implant Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Basic Dental Implant Systems, 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.