TPLC - Total Product Life Cycle

• Device: mouthguard, over-the-counter
• Definition: To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
• Product Code: OBR
• Device Class: Unclassified

Premarket Reviews
Manufacturer	Decision
BOYD RESEARCH, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIMEDIKOREA
	SUBSTANTIALLY EQUIVALENT	1
DOC BRANDS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ENCORE GUARDS
	SUBSTANTIALLY EQUIVALENT	1
FBCC, INC.
	SUBSTANTIALLY EQUIVALENT	1
REAZEAL CORP
	SUBSTANTIALLY EQUIVALENT	1
REMI
	SUBSTANTIALLY EQUIVALENT	1
SPLINTEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN YIZHOU IMP. & EXP. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	10	10
2022	6	6
2023	5	5
2024	18	18
2025	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	17	17
Insufficient Information	6	6
Patient-Device Incompatibility	3	3
Product Quality Problem	3	3
Fitting Problem	2	2
Off-Label Use	2	2
Patient Device Interaction Problem	2	2
Use of Device Problem	2	2
Unexpected Therapeutic Results	2	2
Material Split, Cut or Torn	1	1
Component Missing	1	1
Device Handling Problem	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Tooth Fracture	14	14
Insufficient Information	7	7
Choking	5	5
No Clinical Signs, Symptoms or Conditions	4	4
Pain	2	2
Deformity/ Disfigurement	2	2
Hypersensitivity/Allergic reaction	1	1
Speech Disorder	1	1
Unspecified Musculoskeletal problem	1	1
Foreign Body In Patient	1	1
Discomfort	1	1
Abscess	1	1
Bruxism	1	1
Joint Contracture	1	1
Hemorrhage/Bleeding	1	1
Sensitivity of Teeth	1	1