K260790
- 510(k) number
- K260790
- Device name
- G-Series Grind Guard
- Applicant
- ASESSO HEALTH, Inc. CA · US
- Product code
- OBR — Mouthguard, Over-The-Counter
- Decision date
- 2026-06-25
- Date received
- 2026-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K260790
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.