Device Classification Name |
bracket, ceramic, orthodontic
|
510(k) Number |
K052245 |
Device Name |
ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS |
Applicant |
LAR MFG., LLC. |
2454 MCMULLEN BOOTH ROAD |
SUITE 427 |
CLEARWATER,
FL
33759
|
|
Applicant Contact |
IAN P GORDON |
Correspondent |
LAR MFG., LLC. |
2454 MCMULLEN BOOTH ROAD |
SUITE 427 |
CLEARWATER,
FL
33759
|
|
Correspondent Contact |
IAN P GORDON |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 08/17/2005 |
Decision Date | 09/23/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|