← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

OBR — Mouthguard, Over-The-Counter

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
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES

Recent clearances

K260790ASESSO HEALTH, Inc. · 510k2026-06-25
K2524851987 Media Limited · 510k2026-04-10
K253641Owl Dental Lab, Inc. · 510k2026-02-26
K252004Encore Guards · 510k2025-11-25
K251778Remi · 510k2025-10-17
K250456Doc Brands, Inc. · 510k2025-05-19

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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