Tulsa Dental Products, Ltd.: FDA clearances and approvals
Tulsa Dental Products, Ltd. has 8 FDA 510(k) clearances (first 1988, latest 1997), across 5 product codes in 1 review panel. Median 510(k) review time: 89 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 |
|---|---|---|---|
| EKM | Gutta-Percha | 4 | 4 |
| DZA | Drill, Dental, Intraoral | 1 | 1 |
| EKS | File, Pulp Canal, Endodontic | 1 | 1 |
| ELR | Post, Root Canal | 1 | 1 |
| KIF | Resin, Root Canal Filling | 1 | 1 |
Review panels
- Dental (8)
Most recent Tulsa Dental Products, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970134 | THERMAPREP PLUS OVEN | EKM | 1997-03-21 | 65 |
| K964174 | MINERAL TRIOXIDE AGGREGATE (MTA) | KIF | 1997-02-10 | 115 |
| K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | DZA | 1996-01-16 | 89 |
| K922931 | THERMAPOST ENDODONTIC ROOT CANAL POST | ELR | 1994-05-26 | 708 |
| K933582 | PROFILE SERIES 29 FILES | EKS | 1993-10-20 | 89 |
| K910224 | THERMAPREP | EKM | 1991-03-29 | 70 |
| K900986 | THERMAFIL ENDODONTIC OBTURATOR | EKM | 1990-11-13 | 257 |
| K881139 | THERMAFIL ENDODONTIC OBTURATOR | EKM | 1988-04-07 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Tulsa Dental Products, Ltd..
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 Tulsa Dental Products, Ltd. have?
Tulsa Dental Products, Ltd. has 8 FDA 510(k) clearances (first 1988, latest 1997), across 5 product codes in 1 review panel.
How long does FDA take to clear Tulsa Dental Products, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Tulsa Dental Products, Ltd.'s cleared 510(k)s is 89 days.
What devices does Tulsa Dental Products, Ltd. make?
Its most frequent FDA product codes are EKM (Gutta-Percha, 4); DZA (Drill, Dental, Intraoral, 1); EKS (File, Pulp Canal, Endodontic, 1).
Has Tulsa Dental Products, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tulsa Dental Products, Ltd. Related entities may recall under other names.
Next steps
- See all 8 Tulsa Dental Products, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EKM, Tulsa Dental Products, Ltd.'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.