Device Classification Name |
Bracket, Metal, Orthodontic
|
510(k) Number |
K922499 |
Device Name |
REFLECTIONS - CERAMIC DENTAL BRACKET |
Applicant |
CDB CORP. |
3625 HIGHWAY 421 NORTH |
WILMINGTON,
NC
28401
|
|
Applicant Contact |
SYLVIA C JOYE |
Correspondent |
CDB CORP. |
3625 HIGHWAY 421 NORTH |
WILMINGTON,
NC
28401
|
|
Correspondent Contact |
SYLVIA C JOYE |
Regulation Number | 872.5410
|
Classification Product Code |
|
Date Received | 05/27/1992 |
Decision Date | 07/30/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|