OBRUnclassified

Mouthguard, Over-The-Counter

Unknown

OBR is the FDA product code for Mouthguard, Over-The-Counter. FDA's definition for this code reads: "To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding". As of 2026-09-10, FDA records hold 46 510(k) clearances under this code, the most recent dated 2026-06-25, and no recalls.

Classification record

Product code: OBR
Device name: Mouthguard, Over-The-Counter
FDA definition: To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Device class: Unclassified
Review panel: Unknown
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 47
Ingested recalls: 0

Clearances, product code OBR

By decision year

47 clearances under product code OBR with a decision year between 2006 and 2026, 2008 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code OBR by decision year
Year	Clearances
2006	1
2007	2
2008	5
2009	3
2010	2
2011	1
2012	4
2013	2
2014	2
2015	1
2016	1
2017	1
2018	2
2019	3
2020	3
2021	2
2022	2
2023	1
2024	2
2025	3
2026	4

Applicants with the most clearances

Product code OBR

Applicants holding the most 510(k) clearances under product code OBR
Applicant	Clearances
Den Tek Oral Care, Inc.	6
Ranir, LLC	5
Splintek Inc.	3
Boyd Research	2
Doc Brands, Inc.	2
MedTech Products, Inc.	2
Ranir LLC	2
1987 Media Limited	1
ASESSO HEALTH, Inc.	1
Akervall Technologies	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order