Den Tek Oral Care, Inc. · Class U · Cleared Jan 10, 2013
| K-number | K123849 |
| Device name | NEW COMFORT-FIT DENTAL GUARD |
| Applicant | Den Tek Oral Care, Inc. |
| Product code | OBR |
| Device class | Class U |
| Decision date | Jan 10, 2013 |
| Decision | Substantially Equivalent |
| Regulation | — |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov