Southern Dental Industries, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Southern Dental Industries, Inc.” (first 1980, latest 2006), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 69 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 |
|---|---|---|---|
| EMA | Cement, Dental | 7 | 7 |
| EJJ | Alloy, Amalgam | 6 | 6 |
| EBF | Material, Tooth Shade, Resin | 5 | 5 |
| KLE | Agent, Tooth Bonding, Resin | 3 | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
Review panels
- Dental (24)
Most recent Southern Dental Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062065 | RIVA LUTING PLUS | EMA | 2006-11-15 | 118 |
| K062064 | RIVA BOND LC | EMA | 2006-11-09 | 112 |
| K051008 | SET | EMA | 2005-06-15 | 56 |
| K050871 | RIVA PROTECT | EBC | 2005-06-10 | 65 |
| K050870 | RIVA LIGHT CURE | EMA | 2005-06-03 | 58 |
| K050331 | ADHESIVE 1 | KLE | 2005-03-24 | 42 |
| K042452 | RIVA SILVER | EMA | 2004-12-07 | 88 |
| K040393 | RIVA LUTING | EMA | 2004-04-30 | 73 |
| K032152 | BENCO ADMIX | EJJ | 2003-08-06 | 70 |
| K031658 | BENCO SPHERICAL | EJJ | 2003-07-29 | 62 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Southern Dental Industries, 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.
- Southern Implants (Pty), Ltd. (19 510(k)s)
- Southern Medical (Pty) , Ltd. (6 510(k)s)
- Southern Implants, Inc. (5 510(k)s)
- Southern Spine, LLC (4 510(k)s)
- Southern Medical Products, Inc. (2 510(k)s)
- Southern Exposure, Inc. (1 510(k)s)
- Southern Pride Manufacturing, Inc. (1 510(k)s)
- Southern Research, Inc. (1 510(k)s)
- Southern Rubber Industries Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Southern Dental Industries, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Southern Dental Industries, Inc.” (first 1980, latest 2006), across 6 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 Southern Dental Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Southern Dental Industries, Inc. is 69 days.
Which FDA product codes appear under Southern Dental Industries, Inc.?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 7); EJJ (Alloy, Amalgam, 6); EBF (Material, Tooth Shade, Resin, 5).
Next steps
- See all 24 Southern Dental Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EMA, Southern Dental Industries, 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.