Device Classification Name |
Resin, Denture, Relining, Repairing, Rebasing
|
510(k) Number |
K110037 |
Device Name |
PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID |
Applicant |
HERAEUS KULZER, LLC |
300 HERAEUS WAY |
SOUTH BEND,
IN
46614
|
|
Applicant Contact |
CHERYL ZIMMERMAN |
Correspondent |
HERAEUS KULZER, LLC |
300 HERAEUS WAY |
SOUTH BEND,
IN
46614
|
|
Correspondent Contact |
CHERYL ZIMMERMAN |
Regulation Number | 872.3760
|
Classification Product Code |
|
Date Received | 01/06/2011 |
Decision Date | 04/29/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|