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FDA 510(k)

G-Series Grind Guard

K-Number: K260790 · 2026-06-25

ApplicantASESSO HEALTH, Inc.
Decision Date2026-06-25
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

G-Series Grind Guard is the device name listed in this FDA 510(k) record. The listed applicant is ASESSO HEALTH, Inc.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K260790. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-Series Grind Guard?

G-Series Grind Guard is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is ASESSO HEALTH, Inc.. The 510(k) number is K260790.

When did G-Series Grind Guard receive FDA 510(k) clearance?

G-Series Grind Guard received FDA 510(k) clearance on 2026-06-25, under 510(k) number K260790.

Who is the listed applicant for G-Series Grind Guard?

The FDA 510(k) record lists ASESSO HEALTH, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G-Series Grind Guard?

The FDA product code for G-Series Grind Guard is OBR. This falls under the Orthopedic category.

Related Devices (Code: OBR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media LimitedK253641Owl Night GuardOwl Dental Lab, Inc.K252004enCore Night GuardEncore GuardsK251778Remi Custom Night GuardRemiK250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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