TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
AMPOWER DENTAL LABORATORIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
BELPORT COMPANY, INC., GINGI-PAK
	SUBSTANTIALLY EQUIVALENT	1
BERNHARD FÖRSTER GMBH
	SUBSTANTIALLY EQUIVALENT	1
DENTONA AG
	SUBSTANTIALLY EQUIVALENT	1
DETAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
DMG DIGITAL ENTERPRISES SE
	SUBSTANTIALLY EQUIVALENT	1
ENVISIONTEC GMBH
	SUBSTANTIALLY EQUIVALENT	1
FORMLABS OHIO, INC.
	SUBSTANTIALLY EQUIVALENT	2
FREY ORAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
GRINDGUARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
HKABLE 3D BIOLOGIC PRINTING TECHNOLOGY(CHONGQING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LIJIA, LLC
	SUBSTANTIALLY EQUIVALENT	1
LUXCREO, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIS INVESTMENT GROUP
	SUBSTANTIALLY EQUIVALENT	1
MYCONE DENTAL SUPPLY CO. INC. (DBA KEYSTONE INDUSTRIES)
	SUBSTANTIALLY EQUIVALENT	1
MYOHEALTH TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
PANTHERA DENTAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRISMATIK DENTALCRAFT, INC.
	SUBSTANTIALLY EQUIVALENT	2
PRO3DURE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PRO3DURE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
REMVIA
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HUGE DENTAL MATERIAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SLOW WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPLINTEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPRINTRAY, INC.
	SUBSTANTIALLY EQUIVALENT	1
VERTEX-DENTAL B.V.
	SUBSTANTIALLY EQUIVALENT	1
WHIP MIX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	218	218
Insufficient Information	191	191
Patient-Device Incompatibility	8	8
Patient Device Interaction Problem	5	5
Biocompatibility	2	2
Contamination	1	1
Failure to Osseointegrate	1	1
Product Quality Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Appropriate Term/Code Not Available	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	302	302
Swelling/ Edema	26	26
Discomfort	18	18
Inflammation	14	14
Pain	13	13
Blister	10	10
Itching Sensation	9	9
Burning Sensation	7	7
Dyspnea	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Ulcer	5	5
Numbness	4	4
Unspecified Infection	3	3
Rash	3	3
Insufficient Information	3	3
Nausea	2	2
Cough	2	2
Unspecified Tissue Injury	2	2
Dysphagia/ Odynophagia	2	2
Joint Contracture	2	2
Hemorrhage/Bleeding	2	2
Stomatitis	2	2
Failure of Implant	1	1
Skin Inflammation/ Irritation	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Anaphylactoid	1	1
Muscular Rigidity	1	1
Choking	1	1
Encephalitis	1	1
Dehydration	1	1
Abscess	1	1
Neck Stiffness	1	1
Pressure Sores	1	1
Headache	1	1
Tinnitus	1	1
Deformity/ Disfigurement	1	1
Dysgeusia	1	1