Device Classification Name |
Adhesive, Bracket And Tooth Conditioner, Resin
|
510(k) Number |
K250015 |
Device Name |
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive |
Applicant |
Ormco Corporation |
200 S Kraemer Blvd |
Brea,
CA
92821
|
|
Applicant Contact |
Tara Bonny |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 872.3750
|
Classification Product Code |
|
Date Received | 01/02/2025 |
Decision Date | 01/03/2025 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|