Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K042196
Device Classification Name
Activator, Ultraviolet, For Polymerization
More FDA Info for this Device
510(K) Number
K042196
Device Name
Activator, Ultraviolet, For Polymerization
Applicant
DENFOTEX LIGHT SYSTEMS LTD
UNIT 15, BELLEKNOWES IND.EST
INVERKEITHING FIFE, SCOTLAND KY11 1H7 GB
Other 510(k) Applications for this Company
Contact
JOHN COLLES
Other 510(k) Applications for this Contact
Regulation Number
872.6070
More FDA Info for this Regulation Number
Classification Product Code
EBZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/13/2004
Decision Date
11/01/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact