TPLC - Total Product Life Cycle

• Device: material, tooth shade, resin
• Product Code: EBF
• Regulation Number: 872.3690
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M COMPANY ESPE DENTAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
3M ESPE DENTAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BEGO BREMER GOLDSCHLÄGEREI WILH. HERBST GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
BIODEN CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BIOLOREN S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
COLTENE/WHALEDENT AG
	SUBSTANTIALLY EQUIVALENT	3
COSMEDENT, INC
	SUBSTANTIALLY EQUIVALENT	2
CREAMED GMBH & CO. PRODUKTIONS- UND HANDELS KG
	SUBSTANTIALLY EQUIVALENT	1
DELTAMED GMBH
	SUBSTANTIALLY EQUIVALENT	1
DENTKIST, INC.
	SUBSTANTIALLY EQUIVALENT	1
DENTSCARE LTDA
	SUBSTANTIALLY EQUIVALENT	5
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	1
DETAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
DIADENT GROUP INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	3
DMG USA INC.
	SUBSTANTIALLY EQUIVALENT	1
ENVISIONTEC GMBH
	SUBSTANTIALLY EQUIVALENT	1
FIGARO CROWNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GC AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	2
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GENOSS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
GRAPHENANO DENTAL S.L.
	SUBSTANTIALLY EQUIVALENT	1
GRAPHY INC.
	SUBSTANTIALLY EQUIVALENT	1
GREENWAY YW LLC
	SUBSTANTIALLY EQUIVALENT	1
HDI, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
	SUBSTANTIALLY EQUIVALENT	1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS
	SUBSTANTIALLY EQUIVALENT	1
IVOCLAR VIVADENT AG
	SUBSTANTIALLY EQUIVALENT	1
IVOCLAR VIVADENT, AG
	SUBSTANTIALLY EQUIVALENT	1
KERR CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KULZER, LLC
	SUBSTANTIALLY EQUIVALENT	1
KURARAY NORITAKE DENTAL INC.
	SUBSTANTIALLY EQUIVALENT	2
META BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
NOBIO LTD.
	SUBSTANTIALLY EQUIVALENT	4
PAC-DENT, INC.
	SUBSTANTIALLY EQUIVALENT	2
PARKELL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PERFECT FIT CROWNS, LLC
	SUBSTANTIALLY EQUIVALENT	1
PREMIER DENTAL PRODUCTS COMPANY
	SUBSTANTIALLY EQUIVALENT	1
PULPDENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE ORTHODONTIC PRODUCTS, INC
	SUBSTANTIALLY EQUIVALENT	1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	2
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN GMBH
	SUBSTANTIALLY EQUIVALENT	2
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITATEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
SAREMCO DENTAL AG
	SUBSTANTIALLY EQUIVALENT	1
SDI LIMITED
	SUBSTANTIALLY EQUIVALENT	2
SHOFU DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
SPRINTRAY INC.
	SUBSTANTIALLY EQUIVALENT	1
TOKUYAMA DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
ULTRADENT PRODUCT, INC.
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VOCO GMBH
	SUBSTANTIALLY EQUIVALENT	4
ZIRKONZAHN SRL
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	8	8
2019	11	11
2020	2	2
2021	2	2
2022	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	9	9
Appropriate Term/Code Not Available	9	9
Patient-Device Incompatibility	7	7
Off-Label Use	1	1
Improper or Incorrect Procedure or Method	1	1
Expiration Date Error	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	9	9
No Code Available	7	7
Rash	5	5
Sensitivity of Teeth	4	4
Swelling	3	3
Pain	3	3
Hair Loss	2	2
Discomfort	2	2
Malaise	1	1
Blister	1	1
Low Blood Pressure/ Hypotension	1	1
Inflammation	1	1
Abscess	1	1
Autoimmune Disorder	1	1
Chest Pain	1	1
Dyspnea	1	1
Erythema	1	1
Fatigue	1	1
Thyroid Problems	1	1
Burning Sensation	1	1
Tooth Fracture	1	1
Irregular Pulse	1	1
Intraoperative Pain	1	1
Tissue Breakdown	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ivoclar Vivadent, Inc.	III	Feb-21-2018
2	RHONDIUM LIMITED	II	Dec-19-2019
3	Ultradent Products, Inc.	II	Oct-02-2020
4	Voco GmbH	II	Oct-01-2019