Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K102034
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K102034
Device Name
Implant, Endosseous, Root-Form
Applicant
BLUE SKY BIO, LLC
888 E BELVIDERE RD.
SUITE 212
GRAYSLAKE, IL 60030 US
Other 510(k) Applications for this Company
Contact
ALBERT ZICKMANN
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
07/19/2010
Decision Date
04/19/2011
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
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact