Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K153064 |
Device Name |
Blue Sky Bio Zygomatic Implant System |
Applicant |
BLUE SKY BIO, LLC |
888 E BELVIDERE RD. |
SUITE 212 |
GRAYSLAKE,
IL
60030
|
|
Applicant Contact |
Michele Vovolka |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Kevin A Thomas |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/22/2015 |
Decision Date | 04/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|