G-Series Grind Guard— 510(k) K260790
Substantially EquivalentASESSO HEALTH, Inc.
FDA 510(k) clearance K260790 for G-Series Grind Guard, Substantially Equivalent on 2026-06-25. Applicant: ASESSO HEALTH, Inc.. Device class: Unclassified.
Summary
ASESSO HEALTH's G-Series Grind Guard is filed under OBR, over-the-counter mouthguards. The record doesn't describe the guard beyond its name and the code name.
The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The Dental review panel handled it as a Traditional 510(k).
ASESSO HEALTH filed from Pleasanton, California. Review took 106 calendar days (March 11 to June 25, 2026).
Clearance details
- Applicant
- ASESSO HEALTH, Inc.
- Product code
- Product code OBR
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code OBR
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