TPLC - Total Product Life Cycle

• Device: cement, dental
• Product Code: EMA
• Regulation Number: 872.3275
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
3M DEUTSCHLAND GMBH
	SUBSTANTIALLY EQUIVALENT	2
3M ESPE AG
	SUBSTANTIALLY EQUIVALENT	1
3M ESPE AG DENTAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	3
3M ESPE DENTAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	2
BISCO, INC.
	SUBSTANTIALLY EQUIVALENT	3
COLTENE/WHALEDENT AG
	SUBSTANTIALLY EQUIVALENT	3
CROWN DELTA CORP.
	SUBSTANTIALLY EQUIVALENT	1
DENALI CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
DENALI R&D CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
DENTSCARE LTDA
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	2
DETAX GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
DFL INDUSTRIA E COMERCIO S.A.
	SUBSTANTIALLY EQUIVALENT	2
DIADENT GROUP INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
DMG USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
DOXA AB
	SUBSTANTIALLY EQUIVALENT	1
DOXA DENTAL AB
	SUBSTANTIALLY EQUIVALENT	2
ESSENTIAL DENTAL SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
ESSENTIAL DENTAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXACTA DENTAL DIRECT, INC
	SUBSTANTIALLY EQUIVALENT	1
GAIA DENTAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GC AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	5
GC AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	3
HARRY J. BOSWORTH CO.
	SUBSTANTIALLY EQUIVALENT	1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
	SUBSTANTIALLY EQUIVALENT	2
ITENA CLINICAL
	SUBSTANTIALLY EQUIVALENT	4
IVOCLAR VIVADENT AG
	SUBSTANTIALLY EQUIVALENT	2
IVOCLAR VIVADENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
KERR CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
KETTENBACH GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
KURARAY MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
KURARAY NORITAKE DENTAL INC.
	SUBSTANTIALLY EQUIVALENT	3
KURARAY NORITAKE DENTAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
META BIOMED CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
NOVOCOL, INC.
	SUBSTANTIALLY EQUIVALENT	1
OROSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
PARKELL, INC
	SUBSTANTIALLY EQUIVALENT	1
1.  K210259  Parkell Self-Adhesive Cement
PARKELL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PREMIER DENTAL COMPANY PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
PREVEST DENPRO LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PRIME DENTAL MANUFACTURING, INC.
	SUBSTANTIALLY EQUIVALENT	1
PULPDENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
S & C POLYMER GMBH
	SUBSTANTIALLY EQUIVALENT	3
SDI LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HUGE DENTAL MATERIAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SHOFU DENTAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
SHOFU DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
SILMET LTD.
	SUBSTANTIALLY EQUIVALENT	1
SPIDENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
STEINER LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
SYBRON DENTAL SPECIALTIES
	SUBSTANTIALLY EQUIVALENT	2
TEMREX CORP.
	SUBSTANTIALLY EQUIVALENT	1
TOKUYAMA DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS INC. / ORATECH LLC
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	3
VERICOM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VOCO GMBH
	SUBSTANTIALLY EQUIVALENT	10

MDR Year	MDR Reports	MDR Events
2014	207	207
2015	85	85
2016	16	16
2017	13	13
2018	4	4
2019	12	12
2020	5	5
2021	8	8
2022	3	3
2023	6	6
2024	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Family Dollar Stores, Llc.	II	Nov-07-2023
2	Family Dollar Stores, Llc.	II	Aug-17-2022
3	Henry Schein, Inc.	II	Jan-11-2012
4	Kerr Corp	III	Oct-23-2009
5	Kerr Corporation	II	Mar-14-2012
6	Kerr Corporation	II	Feb-24-2012
7	Kerr Corporation	II	Jan-11-2012
8	Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical	II	Apr-29-2020
9	Kerr/pentron Dba Kerr Corporation And Pentron Clinical	II	Jan-11-2012
10	Kerr/pentron Dba Kerr Corporation And Pentron Clinical	II	Nov-14-2011
11	Preat Corp	III	Mar-06-2023
12	Voco GmbH	II	Feb-16-2024