Den Tek Oral Care, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Den Tek Oral Care, Inc.” (first 2007, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 27 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 | 2 | 99 |
| 2014 | 0 | — |
| 2015 | 1 | 153 |
| 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 |
|---|---|---|---|
| OBR | Mouthguard, Over-The-Counter | 6 | 6 |
| EFW | Toothbrush, Manual | 1 | 1 |
| MQC | Mouthguard, Prescription | 1 | 1 |
Review panels
- Dental (8)
Most recent Den Tek Oral Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151149 | Ready-Fit | OBR | 2015-09-30 | 153 |
| K130186 | DENTEK EASY BRUSH WITH FLUORIDE | EFW | 2013-07-15 | 171 |
| K123849 | NEW COMFORT-FIT DENTAL GUARD | OBR | 2013-01-10 | 27 |
| K091660 | CUSTOM COMFORT NIGHTGUARD VERSION 2 | OBR | 2009-06-12 | 3 |
| K083400 | CUSTOM COMFORT NIGHTGUARD | OBR | 2008-12-11 | 24 |
| K081669 | IMPROVED COMFORT-FIT NIGHTGUARD | OBR | 2008-07-10 | 27 |
| K072147 | DEN TEK COMFORT FIT NIGHTGUARD | OBR | 2007-08-30 | 27 |
| K063483 | DEN TEK NIGHTGUARD | MQC | 2007-01-23 | 67 |
Recalls
openFDA lists no recalls under a recalling firm named Den Tek Oral Care, 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 Den Tek Oral Care, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Den Tek Oral Care, Inc.” (first 2007, latest 2015), across 3 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 Den Tek Oral Care, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Den Tek Oral Care, Inc. is 27 days.
Which FDA product codes appear under Den Tek Oral Care, Inc.?
The most frequent FDA product codes under this applicant name are OBR (Mouthguard, Over-The-Counter, 6); EFW (Toothbrush, Manual, 1); MQC (Mouthguard, Prescription, 1).
Next steps
- See all 8 Den Tek Oral Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OBR, Den Tek Oral Care, 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.