TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	7
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	19
CONFI-DENTAL PRODUCTS CO.
	SUBSTANTIALLY EQUIVALENT	6
DENTSPLY TULSA DENTAL SPECIALTIES
	SUBSTANTIALLY EQUIVALENT	2
ESPE DENTAL
	SUBSTANTIALLY EQUIVALENT	6
IVOCLAR VIVADENT, INC.
	SUBSTANTIALLY EQUIVALENT	8
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	15
KERR CORP.
	SUBSTANTIALLY EQUIVALENT	12
KULZER
	SUBSTANTIALLY EQUIVALENT	14
STAR DENTAL MFG. CO.
	SUBSTANTIALLY EQUIVALENT	1
SYBRON
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	13

Device Problems
Loss of or failure to bond	11
Contamination during use	5
Failure to Adhere or Bond	3
Loose	1
Use of Device Issue	1
Improper or incorrect procedure or method	1
Unknown (for use when the device problem is not known)	1
Dislodged or dislocated	1
No Known Device Problem	1
No Information	1
Total Device Problems	26

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

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Espe Dental Products	II	May-11-2007
2	Kerr Corp	II	Nov-25-2008
3	Kerr Corporation	II	Feb-28-2012
4	Kerr/pentron Dba Kerr Corporation And Pentron Clinical	III	Nov-03-2011
5	Patterson Dental Supply, Inc.	II	Dec-17-2010
6	Sybron Dental Specialties	II	Feb-13-2012
7	Sybron Dental Specialties	II	Feb-11-2012
8	Sybron Dental Specialties	III	Mar-02-2010