Device Classification Name |
scaler, ultrasonic
|
510(k) Number |
K122748 |
Device Name |
ENGLER 25K SERIES ULTRASONIC INSERTS |
Applicant |
ENGLER ENGINEERING CORP. |
1099 EAST 47TH ST. |
HIALEAH,
FL
33013
|
|
Applicant Contact |
JOEL KATZ |
Correspondent |
ENGLER ENGINEERING CORP. |
1099 EAST 47TH ST. |
HIALEAH,
FL
33013
|
|
Correspondent Contact |
JOEL KATZ |
Regulation Number | 872.4850
|
Classification Product Code |
|
Date Received | 09/07/2012 |
Decision Date | 06/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|