Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K100932
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K100932
Device Name
Implant, Endosseous, Root-Form
Applicant
PRISMATIK DENTALCRAFT, INC.
4141 MACARTHUR BLVD
NEWPORT BEACH, CA 92660 US
Other 510(k) Applications for this Company
Contact
KEITH ALLRED
Other 510(k) Applications for this Contact
Regulation Number
872.3640
More FDA Info for this Regulation Number
Classification Product Code
DZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/05/2010
Decision Date
12/27/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact