| Device Classification Name |
Adhesive, Bracket And Tooth Conditioner, Resin
|
| 510(k) Number |
K001881 |
| Device Name |
IMPROVED ENLIGHT LV |
| Applicant |
| SYBRON DENTAL SPECIALTIES, INC. |
| 1717 WEST COLLINS AVE. |
|
ORANGE,
CA
92867
|
|
| Applicant Contact |
COLLEEN BOSWELL |
| Correspondent |
| SYBRON DENTAL SPECIALTIES, INC. |
| 1717 WEST COLLINS AVE. |
|
ORANGE,
CA
92867
|
|
| Correspondent Contact |
COLLEEN BOSWELL |
| Regulation Number | 872.3750 |
| Classification Product Code |
|
| Date Received | 06/21/2000 |
| Decision Date | 08/22/2000 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|