TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
3M DEUTSCHLAND GMBH
	SUBSTANTIALLY EQUIVALENT	2
B&E KOREA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHEMOMENT MATERIALS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
COLTÈNE/WHALEDENT AG
	SUBSTANTIALLY EQUIVALENT	1
DREVE DENTAMID GMBH
	SUBSTANTIALLY EQUIVALENT	2
GC AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	1
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HDI, INC.
	SUBSTANTIALLY EQUIVALENT	1
HRS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HYGEDENT INC.
	SUBSTANTIALLY EQUIVALENT	3
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
NEOSIL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
NO STRESS IMPRESS LLC
	SUBSTANTIALLY EQUIVALENT	1
OSSTEM IMPLANT CO LTD
	SUBSTANTIALLY EQUIVALENT	1
OSSTEM IMPLANT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
OSSTEM IMPLANT CO., LTD..
	SUBSTANTIALLY EQUIVALENT	1
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	53	53
Adverse Event Without Identified Device or Use Problem	37	37
Improper or Incorrect Procedure or Method	7	7
Difficult to Remove	4	4
Use of Device Problem	4	4
Appropriate Term/Code Not Available	3	3
Positioning Failure	2	2
Off-Label Use	2	2
Device Appears to Trigger Rejection	2	2
Material Disintegration	1	1
Loose or Intermittent Connection	1	1
Contamination /Decontamination Problem	1	1
Device Operates Differently Than Expected	1	1
Device Contamination with Chemical or Other Material	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Integrity Problem	1	1
Device Handling Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	52	52
Reaction	11	11
Swelling	9	9
Burning Sensation	5	5
Dyspnea	5	5
Ulcer	5	5
No Code Available	5	5
Foreign Body In Patient	4	4
No Known Impact Or Consequence To Patient	4	4
No Clinical Signs, Symptoms or Conditions	4	4
Discomfort	3	3
Patient Problem/Medical Problem	2	2
Swelling/ Edema	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Inflammation	2	2
Itching Sensation	2	2
Tingling	2	2
No Consequences Or Impact To Patient	2	2
Pain	2	2
Rash	2	2
Local Reaction	1	1
Respiratory Distress	1	1
Laceration(s)	1	1
Irritation	1	1
Foreign Body Reaction	1	1
Hemorrhage/Bleeding	1	1
Abdominal Pain	1	1
Anaphylactic Shock	1	1
Complaint, Ill-Defined	1	1
Injury	1	1
Sore Throat	1	1
Numbness	1	1
Tooth Fracture	1	1
Skin Inflammation	1	1
Tissue Breakdown	1	1

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