Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K143694 |
Device Name |
Rhondium One-Visit-Crown(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 | 872.3690
|
Classification Product Code |
|
Date Received | 12/24/2014 |
Decision Date | 05/15/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|