DenTek Fresh Protect Dental Guard
FDA 510(k) K202974 · Medtech Products, Inc.
510(k) numberK202974
Submission
- Device name
- DenTek Fresh Protect Dental Guard
- Applicant
- Medtech Products, Inc.
Tarrytown, NY, US - Received
- September 30, 2020
- Decision date
- December 22, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K242803 | Compound W Skin Tag RemoverGEH · Traditional | 11/06/2024SE |
| K180933 | DenTek Ultimate Dental GuardOBR · Traditional | 09/17/2018SE |
| K172373 | Compound W Nitro-FreezeGEH · Traditional | 11/02/2017SE |
| K163401 | Nix Ultra Lice Treatment KitLJL · Traditional | 03/21/2017SE |
| K161294 | Compound W Wart Removal System Dual PowerGEH · Traditional | 09/15/2016SE |
| K063401 | Banana RibbedHIS · Abbreviated | 03/26/2007SE |
| K012969 | Double Springers Nonoxnol 9 CondomLTZ · Abbreviated | 06/12/2002SE |
| K993737 | Mighty Man (Dynamic Linkers)HIS · Abbreviated | 03/20/2000SE |
| K993735 | Double SpringersHIS · Abbreviated | 03/20/2000SE |
| K993733 | Love LockersHIS · Abbreviated | 03/20/2000SE |
Questions and answers
When was DenTek Fresh Protect Dental Guard cleared by the FDA?
DenTek Fresh Protect Dental Guard (K202974) received a 510(k) decision of Substantially Equivalent on December 22, 2020, 83 days after the submission was received.
What is the product code of K202974?
The FDA product code is OBR – Mouthguard, Over-The-Counter, a Unclassified device.