Device Classification Name |
Cleanser, Root Canal
|
510(k) Number |
K003422 |
Device Name |
EDTA ROOT CANAL CLEANSER |
Applicant |
SUPER GLIDE, INC. |
227 COLCHESTER AVE. |
BURLINGTON,
VT
05401
|
|
Applicant Contact |
VICTOR L RATKUS |
Correspondent |
SUPER GLIDE, INC. |
227 COLCHESTER AVE. |
BURLINGTON,
VT
05401
|
|
Correspondent Contact |
VICTOR L RATKUS |
Classification Product Code |
|
Date Received | 11/03/2000 |
Decision Date | 01/19/2001 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|