Device Classification Name |
Bracket, Ceramic, Orthodontic
|
510(k) Number |
K141104 |
FOIA Releasable 510(k) |
K141104
|
Device Name |
TRUKLEAR BRACKET |
Applicant |
AJW TECHNOLOGY CONSULTANTS, INC. |
445 APOLLO BEACH BLVD |
APOLLO BEACH,
FL
33572
|
|
Applicant Contact |
TANYA O'BRIEN |
Correspondent |
AJW TECHNOLOGY CONSULTANTS, INC. |
445 APOLLO BEACH BLVD |
APOLLO BEACH,
FL
33572
|
|
Correspondent Contact |
TANYA O'BRIEN |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 04/29/2014 |
Decision Date | 06/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|