Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FBCC Night Guard

K-Number: K221369 · 2022-11-18

ApplicantFbcc, Inc.
Decision Date2022-11-18
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

FBCC Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Fbcc, Inc.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K221369. 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 FBCC Night Guard?

FBCC Night Guard is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Fbcc, Inc.. The 510(k) number is K221369.

When did FBCC Night Guard receive FDA 510(k) clearance?

FBCC Night Guard received FDA 510(k) clearance on 2022-11-18, under 510(k) number K221369.

Who is the listed applicant for FBCC Night Guard?

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

What is the FDA product code for FBCC Night Guard?

The FDA product code for FBCC Night 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.

K260790G-Series Grind GuardASESSO HEALTH, Inc.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.

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.

↑