Device Classification Name |
powder, porcelain
|
510(k) Number |
K162677 |
Device Name |
L- OVC |
Applicant |
Rhondium, Ltd |
4 Sheffield Street |
Katikati,
NZ
3129
|
|
Applicant Contact |
Greer Fricker |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Kevin A. Thomas |
Regulation Number | 872.6660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/26/2016 |
Decision Date | 12/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|