Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K182296 |
Device Name |
HyperFil-LV |
Applicant |
Parkell, Inc. |
300 Executive Drive |
Edgewood,
NY
11717
|
|
Applicant Contact |
David Mott |
Correspondent |
Parkell, Inc. |
300 Executive Drive |
Edgewood,
NY
11717
|
|
Correspondent Contact |
David Mott |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 08/24/2018 |
Decision Date | 12/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|