Company ยท US
Den Tek Oral Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2015. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2015 | K151149 | Ready-Fit Den Tek Oral Care, Inc. | OBR |
| Jul 15, 2013 | K130186 | DENTEK EASY BRUSH WITH FLUORIDE Den Tek Oral Care, Inc. | EFW |
| Jan 10, 2013 | K123849 | NEW COMFORT-FIT DENTAL GUARD Den Tek Oral Care, Inc. | OBR |
| Jun 12, 2009 | K091660 | CUSTOM COMFORT NIGHTGUARD VERSION 2 Den Tek Oral Care, Inc. | OBR |
| Dec 11, 2008 | K083400 | CUSTOM COMFORT NIGHTGUARD Den Tek Oral Care, Inc. | OBR |
| Jul 10, 2008 | K081669 | IMPROVED COMFORT-FIT NIGHTGUARD Den Tek Oral Care, Inc. | OBR |
| Aug 30, 2007 | K072147 | DEN TEK COMFORT FIT NIGHTGUARD Den Tek Oral Care, Inc. | OBR |
| Jan 23, 2007 | K063483 | DEN TEK NIGHTGUARD Den Tek Oral Care, Inc. | MQC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||