Device Classification Name |
Handpiece, Air-Powered, Dental
|
510(k) Number |
K192412 |
Device Name |
SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece |
Applicant |
DentalEZ, Inc. |
1816 Colonial Village Lane |
Lancaster,
PA
17601
|
|
Applicant Contact |
Robert Young |
Correspondent |
DentalEZ, Inc. |
1816 Colonial Village Lane |
Lancaster,
PA
17601
|
|
Correspondent Contact |
Robert Young |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 09/04/2019 |
Decision Date | 01/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|