New Comfort-Fit Dental Guard
FDA 510(k) K123849 · Den Tek Oral Care, Inc.
510(k) numberK123849
Submission
- Device name
- New Comfort-Fit Dental Guard
- Applicant
- Den Tek Oral Care, Inc.
Maryville, TN, US - Received
- December 14, 2012
- Decision date
- January 10, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBR – Mouthguard, Over-The-Counter
- Device class
- Unclassified
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Other 510(k)s with product code OBR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260790 | G-Series Grind GuardOBR · Traditional | ASESSO HEALTH, Inc. | 06/25/2026SE |
| K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore…OBR · Traditional | 1987 Media Limited | 04/10/2026SE |
| K253641 | Owl Night GuardOBR · Traditional | Owl Dental Lab, Inc. | 02/26/2026SE |
| K252004 | enCore Night GuardOBR · Traditional | Encore Guards | 11/25/2025SE |
| K251778 | Remi Custom Night GuardOBR · Traditional | Remi | 10/17/2025SE |
| K250456 | Dentemp Pro-Comfort Dental GuardOBR · Traditional | Doc Brands, Inc. | 05/19/2025SE |
| K240810 | Anti Grinding GuardOBR · Traditional | Xiamen Yizhou Imp. & Exp. Co., Ltd. | 05/24/2024SE |
| K232238 | Goyo Mouthpiece SOBR · Traditional | Dimedikorea | 04/17/2024SE |
| K231865 | Mouth Guard (ATG0603R)OBR · Traditional | Reazeal Corp | 11/06/2023SE |
| K221369 | FBCC Night GuardOBR · Traditional | Fbcc, Inc. | 11/18/2022SE |
More from Fbcc, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K151149 | Ready-FitOBR · Traditional | 09/30/2015SE |
| K130186 | Dentek Easy Brush with FluorideEFW · Traditional | 07/15/2013SE |
| K091660 | Custom Comfort Nightguard Version 2OBR · Special | 06/12/2009SE |
| K083400 | Custom Comfort NightguardOBR · Special | 12/11/2008SE |
| K081669 | Improved Comfort-Fit NightguardOBR · Special | 07/10/2008SE |
| K072147 | Den Tek Comfort Fit NightguardOBR · Special | 08/30/2007SE |
| K063483 | Den Tek NightguardMQC · Traditional | 01/23/2007SE |
Questions and answers
When was New Comfort-Fit Dental Guard cleared by the FDA?
New Comfort-Fit Dental Guard (K123849) received a 510(k) decision of Substantially Equivalent on January 10, 2013, 27 days after the submission was received.
What is the product code of K123849?
The FDA product code is OBR – Mouthguard, Over-The-Counter, a Unclassified device.