Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Den Tek Oral Care, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
171 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151149 | Ready-Fit | Den Tek Oral Care, Inc. | 2015-09-30 | 153 | 0 |
| K130186 | DENTEK EASY BRUSH WITH FLUORIDE | Den Tek Oral Care, Inc. | 2013-07-15 | 171 | 0 |
| K123849 | NEW COMFORT-FIT DENTAL GUARD | Den Tek Oral Care, Inc. | 2013-01-10 | 27 | 0 |
| K091660 | CUSTOM COMFORT NIGHTGUARD VERSION 2 | Den Tek Oral Care, Inc. | 2009-06-12 | 3 | 0 |
| K083400 | CUSTOM COMFORT NIGHTGUARD | Den Tek Oral Care, Inc. | 2008-12-11 | 24 | 0 |
| K081669 | IMPROVED COMFORT-FIT NIGHTGUARD | Den Tek Oral Care, Inc. | 2008-07-10 | 27 | 0 |
| K072147 | DEN TEK COMFORT FIT NIGHTGUARD | Den Tek Oral Care, Inc. | 2007-08-30 | 27 | 0 |
| K063483 | DEN TEK NIGHTGUARD | Den Tek Oral Care, Inc. | 2007-01-23 | 67 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda