TPLC - Total Product Life Cycle

• Device: agent, tooth bonding, resin
• Product Code: KLE
• Regulation Number: 872.3200
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M DEUTSCHLAND GMBH
	SUBSTANTIALLY EQUIVALENT	1
BELPORT COMPANY, INC., GINGI-PAK
	SUBSTANTIALLY EQUIVALENT	1
DENMAT HOLDING, LLC
	SUBSTANTIALLY EQUIVALENT	1
DENTSCARE LTDA
	SUBSTANTIALLY EQUIVALENT	1
DIADENT GROUP INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	4
GC AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	1
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
	SUBSTANTIALLY EQUIVALENT	1
IVOCLAR VIVADENT, AG
	SUBSTANTIALLY EQUIVALENT	1
KERR CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KETTENBACH GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
KURARAY NORITAKE DENTAL INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICLUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
META BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NOBIO LTD.
	SUBSTANTIALLY EQUIVALENT	1
PAC-DENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
PREVEST DENPRO LIMITED
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE ORTHODONTIC PRODUCTS, INC
	SUBSTANTIALLY EQUIVALENT	1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	2
ROUNDING THIRD LLC
	SUBSTANTIALLY EQUIVALENT	1
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITÄTEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
SDI LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SHOFU DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SINO-DENTEX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TOKUYAMA DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	20	20
2020	6	6
2021	6	6
2022	7	7
2023	7	7
2024	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	20	20
Use of Device Problem	14	14
Adverse Event Without Identified Device or Use Problem	8	8
No Apparent Adverse Event	7	7
Improper or Incorrect Procedure or Method	6	6
Device Handling Problem	2	2
Patient Device Interaction Problem	1	1
Insufficient Information	1	1
Component Missing	1	1
Improper Chemical Reaction	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	20	20
Caustic/Chemical Burns	11	11
Pain	10	10
Burning Sensation	10	10
Swelling	8	8
Edema	7	7
Skin Irritation	6	6
Eye Injury	6	6
Local Reaction	5	5
Discomfort	5	5
Skin Inflammation/ Irritation	3	3
Insufficient Information	2	2
Urticaria	2	2
No Clinical Signs, Symptoms or Conditions	1	1
Tissue Breakdown	1	1
Cough	1	1
Stomatitis	1	1
Blister	1	1
Deformity/ Disfigurement	1	1
Sensitivity of Teeth	1	1
Ulcer	1	1
Erythema	1	1
Autoimmune Reaction	1	1
Dyspnea	1	1
Rash	1	1
Irritation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ultradent Products, Inc.	II	Jul-12-2022