Device Classification Name |
Resin, Denture, Relining, Repairing, Rebasing
|
510(k) Number |
K232691 |
Device Name |
Polibond |
Applicant |
Zirkonzahn Srl |
An der Ahr 7 |
Gais,
IT
39030
|
|
Applicant Contact |
Sorana Siclovan |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 872.3760
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/01/2023 |
Decision Date | 09/05/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|