The following data is part of a premarket notification filed by Dentek Oral Care, Inc. with the FDA for New Comfort-fit Dental Guard.
| Device ID | K123849 |
| 510k Number | K123849 |
| Device Name: | NEW COMFORT-FIT DENTAL GUARD |
| Classification | Mouthguard, Over-the-counter |
| Applicant | DENTEK ORAL CARE, INC. 307 EXCELLENCE WAY Maryville, TN 37801 |
| Contact | Linda Giles |
| Correspondent | Linda Giles DENTEK ORAL CARE, INC. 307 EXCELLENCE WAY Maryville, TN 37801 |
| Product Code | OBR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-14 |
| Decision Date | 2013-01-10 |
| Summary: | summary |