TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
3M DEUTSCHLAND GMBH
	SUBSTANTIALLY EQUIVALENT	1
B&E KOREA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING OKVD BIOLOGICAL TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHEMOMENT MATERIALS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
COLTÈNE/WHALEDENT AG
	SUBSTANTIALLY EQUIVALENT	1
DENT4YOU AG
	SUBSTANTIALLY EQUIVALENT	1
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HDI, INC.
	SUBSTANTIALLY EQUIVALENT	1
HYGEDENT INC.
	SUBSTANTIALLY EQUIVALENT	1
IMICRYL DIS MALZEMELERI SAN. VE TIC. A.S.
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE PRODUCT BRANDS, INC.
	SUBSTANTIALLY EQUIVALENT	1
LASCOD SPA
	SUBSTANTIALLY EQUIVALENT	1
NANCHANG DENTAL BRIGHT TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
NO STRESS IMPRESS LLC
	SUBSTANTIALLY EQUIVALENT	1
OSSTEM IMPLANT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
PREVEST DENPRO LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HUGE DENTAL MATERIAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ZHENGZHOU HUAER ELECTRO OPTICS TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	23	23
Adverse Event Without Identified Device or Use Problem	13	13
Improper or Incorrect Procedure or Method	5	5
Use of Device Problem	3	3
Off-Label Use	2	2
Difficult to Remove	2	2
Positioning Failure	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	25	25
No Clinical Signs, Symptoms or Conditions	4	4
Foreign Body In Patient	3	3
Discomfort	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Insufficient Information	2	2
Dyspnea	2	2
Swelling/ Edema	2	2
Tooth Fracture	1	1
Rash	1	1
Swelling	1	1
Reaction	1	1
Sore Throat	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Clinician's Choice Dental Products Inc.	II	May-17-2022