Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K151455
Device Classification Name
More FDA Info for this Device
510(K) Number
K151455
Device Name
3Shape Abutment Designer Software
Applicant
3Shape A/S
Holemens Kanal 7
Copenhagen 1060 DK
Other 510(k) Applications for this Company
Contact
Hanne Nielsen
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PNP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/2015
Decision Date
09/06/2016
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