Device Classification Name |
Composite Resin Warmer
|
510(k) Number |
K182017 |
Device Name |
Compex HD |
Applicant |
AdDent, Inc. |
43 Miry Brook Road |
Danbury,
CT
06810
|
|
Applicant Contact |
Joshua Friedman |
Correspondent |
AdDent, Inc. |
43 Miry Brook Road |
Danbury,
CT
06810
|
|
Correspondent Contact |
Joshua Friedman |
Regulation Number | 872.6100
|
Classification Product Code |
|
Date Received | 07/27/2018 |
Decision Date | 04/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|