TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
3D DIAGNOSTIX INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED FACIALDONTICS LLC
	SUBSTANTIALLY EQUIVALENT	1
AMANN GIRRBACH AG
	SUBSTANTIALLY EQUIVALENT	1
AMPOWER DENTAL LABORATORIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
BELPORT COMPANY, INC., GINGI-PAK
	SUBSTANTIALLY EQUIVALENT	1
BRUX NIGHT GUARD
	SUBSTANTIALLY EQUIVALENT	1
DENTONA AG
	SUBSTANTIALLY EQUIVALENT	1
DETAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
DMG DIGITAL ENTERPRISES SE
	SUBSTANTIALLY EQUIVALENT	1
ENVISIONTEC GMBH
	SUBSTANTIALLY EQUIVALENT	2
ERKODENT ERICH KOPP GMBH
	SUBSTANTIALLY EQUIVALENT	1
FORMLABS OHIO, INC.
	SUBSTANTIALLY EQUIVALENT	2
FREY ORAL TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
HKABLE 3D BIOLOGIC PRINTING TECHNOLOGY(CHONGQING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KEYSTONE INDUSTRIES
	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 GMBH
	SUBSTANTIALLY EQUIVALENT	2
SPLINTEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPRINTRAY INC
	SUBSTANTIALLY EQUIVALENT	1
VERTEX-DENTAL BV
	SUBSTANTIALLY EQUIVALENT	1
VOCO GMBH
	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	232	232
Insufficient Information	190	190
Patient-Device Incompatibility	4	4
Appropriate Term/Code Not Available	1	1
Device Emits Odor	1	1
Product Quality Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Failure to Osseointegrate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	311	311
Reaction	60	60
Pain	22	22
Swelling	22	22
Burning Sensation	15	15
Irritation	7	7
Rash	6	6
Inflammation	6	6
Itching Sensation	5	5
Pressure Sores	5	5
Numbness	4	4
Ulcer	4	4
No Code Available	4	4
Unspecified Infection	4	4
Swelling/ Edema	4	4
Insufficient Information	3	3
Erythema	3	3
Sore Throat	3	3
Discomfort	3	3
Tingling	3	3
Wheal(s)	2	2
Patient Problem/Medical Problem	2	2
Joint Contracture	2	2
Nausea	2	2
Local Reaction	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Tinnitus	1	1
Peeling	1	1
Muscular Rigidity	1	1
Failure of Implant	1	1
Erosion	1	1
Dyspnea	1	1
Skin Inflammation/ Irritation	1	1
Cramp(s) /Muscle Spasm(s)	1	1
No Information	1	1
Deformity/ Disfigurement	1	1
Sensitivity of Teeth	1	1
Neck Stiffness	1	1
Nasal Obstruction	1	1
Decreased Sensitivity	1	1