TPLC - Total Product Life Cycle

• Device: implant, endosseous, root-form
• Regulation Description: Endosseous dental implant.
• Product Code: DZE
• Regulation Number: 872.3640
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALTATEC GMBH
	SUBSTANTIALLY EQUIVALENT	2
BICON
	SUBSTANTIALLY EQUIVALENT	11
BIOHORIZONS IMPLANT SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	21
BIOLOK INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET
	SUBSTANTIALLY EQUIVALENT	4
CARBOMEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
COLLAGEN
	SUBSTANTIALLY EQUIVALENT	5
DENTIUM CO.
	SUBSTANTIALLY EQUIVALENT	5
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANT INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	37
INNOVA
	SUBSTANTIALLY EQUIVALENT	3
KEYSTONE DENTAL
	SUBSTANTIALLY EQUIVALENT	1
KLS MARTIN GMBH + CO. KG
	SUBSTANTIALLY EQUIVALENT	2
LEIBINGER
	SUBSTANTIALLY EQUIVALENT	1
LIFECORE BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	23
MEDICON, E.G.
	SUBSTANTIALLY EQUIVALENT	2
MONDEAL MEDICAL SYSTEMS GMBH
	SUBSTANTIALLY EQUIVALENT	2
NOBEL BIOCARE
	SUBSTANTIALLY EQUIVALENT	20
ORMCO CORP.
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED
	SUBSTANTIALLY EQUIVALENT	2
SOADCO, S.L.
	SUBSTANTIALLY EQUIVALENT	4
STERNGOLD
	SUBSTANTIALLY EQUIVALENT	7
STRAUMANN
	SUBSTANTIALLY EQUIVALENT	34
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	2
SYBRON
	SUBSTANTIALLY EQUIVALENT	1
W. LORENZ SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	15

Device Problems
Failure to osseointegrate	492
Implant overload	28
Fracture	12
Loss of osseointegration	11
Absorption	7
Difficult to insert	4
No Information	2
Use of Device Issue	1
Failure to Adhere or Bond	1
Explanted	1
Osseointegration issue	1
Break	1
Migration of device or device component	1
No Known Device Problem	1
Unexpected therapeutic results	1
Total Device Problems	564

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	4	0	1	3	1	5	0
Class III	4	3	0	1	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	3m Imtec Corporation	II	May-27-2010
2	BioHorizons Implant Systems Inc	II	Dec-19-2012
3	BioHorizons Implant Systems Inc	II	Nov-04-2010
4	BioHorizons Implant Systems Inc	III	May-11-2007
5	BioHorizons Implant Systems Inc	III	Apr-13-2007
6	Biomedicare, Inc.	II	Jul-23-2007
7	Biomet 3i	II	Sep-18-2007
8	Biomet 3i	II	Jun-19-2007
9	Biomet 3i	II	Jun-14-2007
10	Biomet 3i	III	May-16-2007
11	Biomet 3i, LLC	II	Nov-16-2012
12	Biomet 3i, LLC	II	Oct-23-2012
13	Biomet 3i, LLC	II	Jun-20-2012
14	Biomet 3i, LLC	II	Nov-08-2011
15	Biomet 3i, LLC	II	Feb-22-2010
16	Nobel Biocare USA LLC	III	Sep-19-2008
17	Pro-Dex Inc dba Dyna-Dent	III	Mar-26-2010
18	Straumann Manufacturing Inc.	III	Sep-16-2008
19	Thommen Medical, AG	III	Jul-24-2007
20	Zest Anchors Inc	III	Dec-01-2008
21	Zimmer Inc.	II	May-10-2012
22	Zimmer Inc.	II	Dec-10-2009